Phase 3
Completed N=225
Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Vaccines, Pneumococcal
Source: ClinicalTrials.gov NCT00708682 ↗
Enrolled (actual)
225
Serious AEs
1.3%
Results posted
Feb 2011
Primary outcomePrimary: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series — 100.0; 97.7; 98.2; 98.8 Percentage of participants
Summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series |
100.0; 97.7; 98.2; 98.8; 98.8; 98.2 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series |
100.0; 80.9; 95.9; 99.0; 93.3; 98.5 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose |
100.0; 99.4; 100.0; 100.0; 100.0; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
- Able to complete three blood draws during study
- At least 3.5 kg at enrollment
Exclusion Criteria
- Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
- Immune deficiency, bleeding disorder or significant chronic medical condition
Data sourced from ClinicalTrials.gov (NCT00708682). 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.