Phase 3
Completed N=619
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Vaccines, Pneumococcal
Source: ClinicalTrials.gov NCT00368966 ↗
Enrolled (actual)
619
Serious AEs
3.2%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series — 98.3; 98.9; 95.9; 94.7 Percentage of Participants
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 pediatric vaccinations in Spain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series |
98.3; 98.9; 95.9; 94.7; 100.0; 100.0 | — |
| PRIMARY Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series |
191.22; 266.19 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series |
0.51; 0.63 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
49.5; 43.3; 45.4; 46.6; 47.9; 41.9 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events |
30.5; 24.5; 40.4; 41.7; 34.3; 38.3 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose |
1.89; 2.33; 4.97; 0.42; 3.88; 11.88 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose |
100.0; 100.0; 99.6; 99.6; 93.2; 95.1 | — |
| PRIMARY Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose |
436.98; 436.15; 1057.40; 1286.70; 266.34; 281.85 | — |
| PRIMARY Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose |
1.19; 1.40; 3.00; 3.51; 0.90; 0.87 | — |
| PRIMARY Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose |
51.51; 50.13; 36.13; 36.01; 179.04; 166.77 | — |
| PRIMARY Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose |
96.7; 98.9; 99.2; 57.3; 98.5; 99.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00368966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.