Phase 3
N=449
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00474539 ↗Enrolled (actual)
449
Serious AEs
2.4%
Results posted
Mar 2013
Primary outcome: Primary: 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 — 98.5; 99.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); 7-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
98.5; 99.1 | — |
| PRIMARY 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 |
654.55; 757.04; 2573.06; 2098.12 | — |
| PRIMARY 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 |
98.5; 99.1; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY 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 |
0.79; 0.92; 3.00; 3.23; 1.10; 1.20 | — |
| PRIMARY 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 |
92.5; 98.5; 100.0; 27.9; 94.9; 100.0 | — |
| PRIMARY 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 |
1.55; 2.32; 3.88; 0.21; 2.59; 12.25 | — |
| SECONDARY Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
100.0; 99.4 | — |
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.
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 (NCT00474539). 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.