A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vaccines, Pneumococcal
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 225
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
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
Time Frame: 1 month after the infant series (7 months of age)
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants.
Secondary Outcomes
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series(1 month after dose 2 of the infant series (5 months of age))
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose(1 month after the toddler dose (13 months of age))