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Completed

NCT Number: NCT03656939

A Safety Study For Prevenar 13 Among Chinese Children

This is an observational study based on a population-based EHR database.

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Key information

Conditions

Seizures Angioedema Apnea Body Temperature Changes Cardiovascular Diseases Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Urticaria and Angioedema Vascular Diseases

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Public Health at Fudan University

Shanghai, 200032, China

About this study

This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.

Exclusion criteria

There are no exclusion criteria for this study.

Treatment and study plan

Primary outcomes

  1. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  2. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  3. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  4. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  5. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  6. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  7. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  8. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  9. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  10. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  11. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  12. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  13. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  14. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  15. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  16. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  17. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  18. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  19. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  20. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  21. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  22. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  23. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  24. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  25. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  26. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  27. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  28. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  29. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  30. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  31. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  32. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  33. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  34. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  35. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  36. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  37. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  38. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  39. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  40. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  41. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  42. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  43. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  44. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  45. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  46. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  47. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  48. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  49. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  50. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  51. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  52. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  53. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  54. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  55. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  56. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  57. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  58. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  59. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  60. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  61. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 Days after all Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  62. Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 Days after all Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  63. Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 Days after all Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  64. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 Days after all Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  65. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 Days after all Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  66. Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 Days after all Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  67. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  68. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  69. Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  70. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  71. Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  72. Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

  73. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  74. Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  75. Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

  76. Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  77. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  78. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  79. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  80. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  81. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  82. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  83. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  84. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  85. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  86. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  87. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  88. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1

    Time frame: 0 to 3 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  89. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1

    Time frame: 4 to 7 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  90. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1

    Time frame: 0 to 7 days after Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  91. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  92. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  93. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  94. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  95. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  96. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  97. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  98. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  99. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  100. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  101. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  102. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  103. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2

    Time frame: 0 to 3 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  104. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2

    Time frame: 4 to 7 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  105. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2

    Time frame: 0 to 7 days after Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  106. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  107. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  108. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  109. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  110. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  111. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  112. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  113. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  114. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  115. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  116. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  117. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  118. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3

    Time frame: 0 to 3 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  119. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3

    Time frame: 4 to 7 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  120. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3

    Time frame: 0 to 7 days after Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  121. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  122. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  123. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  124. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  125. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  126. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  127. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  128. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  129. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  130. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  131. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  132. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  133. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4

    Time frame: 0 to 3 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  134. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4

    Time frame: 4 to 7 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  135. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4

    Time frame: 0 to 7 days after Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  136. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  137. Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  138. Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  139. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  140. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  141. Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  142. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  143. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  144. Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

  145. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  146. Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  147. Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

  148. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses

    Time frame: 0 to 3 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

  149. Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses

    Time frame: 4 to 7 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

  150. Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses

    Time frame: 0 to 7 days after all doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2018
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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