A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vaccines, Pneumococcal
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 500
- Primary Endpoint
- Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Time Frame: One month after 3-dose infant series (at 5 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 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.
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Time Frame: One month after 3-dose infant series (at 5 months of age)
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.
Secondary Outcomes
- Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose(one month after the toddler dose (at 13 months of age))
- Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose(one month after the toddler dose (at 13 months of age))