A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pneumococcal Vaccines
- Sponsor
- Pfizer
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy children previously immunized with 1 or 2 doses of Prevenar.
- •Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment.
- •Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment
- •Available for entire study period.
Exclusion Criteria
- •Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
- •Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
Outcomes
Primary Outcomes
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Time Frame: 1 month after the toddler dose (13 months of age)
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Secondary Outcomes
- Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose(1 Month after the infant series (6 months of age))
- GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose(1 Month after the infant series (6 months of age))
- GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose(12 months of age (prior to toddler dose))