A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vaccines, Pneumococcal
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 449
- Primary Endpoint
- Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy 2-month-old infants
- •Available for the entire study period
- •Exclusion criteria:
- •Previous vaccination with any vaccine before the start of the study
- •Known contraindication to vaccination
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Time Frame: One month after infant series dose (at 5 months of age)
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL).
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Secondary Outcomes
- Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose(One month after toddler dose (at 16 months of age))