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Completed

NCT Number: NCT00652951

Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Hoofddorp, 2134 TM, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from both parents or from the guardian(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
  • Children for whom hepatitis B vaccination is required according to the local recommendations
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Treatment and study plan

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)

Biological

Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination

Infanrix™ hexa.

Biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Pediacel™

Biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Prevenar™

Biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Primary outcomes

  1. Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.

  2. Antibody Concentration Against Protein D (PD) - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Secondary outcomes

  1. Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  2. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

  3. Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  4. Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

  5. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.

  6. Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.

  7. Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

  8. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.

  9. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.

  10. Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.

    Time frame: At Month 3, one month after the administration of the third vaccine dose

    Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

  11. Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination

    Time frame: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)

    Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  12. Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination

    Time frame: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)

    Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

  13. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination

    Time frame: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

  14. Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.

    Time frame: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)

    Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  15. Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination

    Time frame: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)

    Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

  16. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.

    Time frame: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

  17. Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.

    Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

  18. Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.

    Time frame: Prior to (Month 9) and one month after (Month 10) the administration of the booster dose

    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.

  19. Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination

    Time frame: Prior to (Month 9) and one month after (Month 10) the administration of the booster dose

    Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

  20. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.

    Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

    Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.

  21. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.

    Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

    Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.

  22. Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.

    Time frame: Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

    Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

  23. Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.

    Time frame: One month after (Month 10) the administration of the booster dose

    A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations < 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).

  24. Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  25. Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

  26. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

  27. Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

  28. Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

  29. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

  30. Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.

    Time frame: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

  31. Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.

    Time frame: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

    Positive cultures of H. influenzae* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.

  32. Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.

    Time frame: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

    Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).

  33. Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.

    Time frame: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

    Acquisition of new H. influenzae* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.

  34. Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.

    Time frame: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

    Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).

  35. Number of Subjects With Solicited Local Symptoms - Primary Vaccination

    Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (>) 30 millimeters from injection site.

  36. Number of Subjects With Solicited General Symptoms - Primary Vaccination

    Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.

  37. Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.

    Time frame: Within the 31-day (Days 0-30) post-primary vaccination

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  38. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: Throughout the entire study period (up to Month 21)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  39. Number of Subjects With Solicited Local Symptoms -Booster Vaccination

    Time frame: During the 4-day (Days 0-3) post-vaccination period following booster dose

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters from injection site.

  40. Number of Subjects With Solicited General Symptoms - Booster Vaccination.

    Time frame: During the 4-day (Days 0-3) post-vaccination period following booster dose

    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.

  41. Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.

    Time frame: Within the 31-day (Days 0-30) after booster vaccination

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 4, 2008
Registry last updated
Jun 26, 2019

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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