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Completed

NCT Number: NCT04379713

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

42 day–98 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Mayo UMCB S.R.L., San Miguel de Tucumán, Tucumán Province, Argentina

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  • Major known congenital malformation or serious chronic disorder.

Treatment and study plan

20-valent pneumococcal conjugate vaccine

Biological

Pneumococcal conjugate vaccine

13-valent Pneumococcal Conjugate Vaccine

Biological

Pneumococcal conjugate vaccine

Primary outcomes

  1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1

    Time frame: Within 7 Days after Dose 1

    Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

  2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2

    Time frame: Within 7 Days after Dose 2

    Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

  3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3

    Time frame: Within 7 Days after Dose 3

    Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

  4. Percentage of Participants With Local Reactions Within 7 Days After Dose 4

    Time frame: Within 7 Days after Dose 4

    Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

  5. Percentage of Participants With Systemic Events Within 7 Days After Dose 1

    Time frame: Within 7 Days after Dose 1

    Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  6. Percentage of Participants With Systemic Events Within 7 Days After Dose 2

    Time frame: Within 7 Days after Dose 2

    Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  7. Percentage of Participants With Systemic Events Within 7 Days After Dose 3

    Time frame: Within 7 Days after Dose 3

    Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  8. Percentage of Participants With Systemic Events Within 7 Days After Dose 4

    Time frame: Within 7 Days after Dose 4

    Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  9. Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

    Time frame: From Dose 1 to 1 Month after Dose 3

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  10. Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4

    Time frame: From Dose 4 to 1 Month after Dose 4

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  11. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4

    Time frame: From Dose 1 to 6 Months after Dose 4

    A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.

  12. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4

    Time frame: From Dose 1 to 6 Months after Dose 4

    An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 7, 2020
Registry last updated
Jun 13, 2023

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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