Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Phase 3

Completed

Conditions: Pneumococcal Vaccines

Interventions: Biological: 13vPnC

Registration Number: NCT00824655

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 234

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	13vPnC	-
Group 2	13vPnC	-

Primary Outcome Measures

Name	Time	Method
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose	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 Outcome Measures

Name	Time	Method
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)	Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based on the observed proportion of participants.
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose	1 Month after the infant series (6 months of age)	Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose	12 months of age (prior to toddler dose)	Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.