Phase 3
Completed N=193
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Vaccines, Pneumococcal Conjugate Vaccine
Source: ClinicalTrials.gov NCT00574795 ↗
Enrolled (actual)
193
Serious AEs
4.2%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series — 100.0; 98.3; 100.0; 100.0 percentage of participants
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series |
100.0; 98.3; 100.0; 100.0; 100.0; 97.2 | — |
| SECONDARY Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series |
6.76; 4.77; 3.39; 14.69; 3.68; 5.71 | — |
| SECONDARY Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose |
100; 100; 100; 100; 100; 98.9 | — |
| SECONDARY Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose |
9.70; 14.61; 4.49; 16.33; 6.09; 12.20 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy 2 to 6 month-old infant
- Available for entire study period
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with a pneumococcal conjugate vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
- Known or suspected immune deficiency or suppression.
Data sourced from ClinicalTrials.gov (NCT00574795). 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.