Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal Conjugate Vaccine

• Registration Number: NCT00574795
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2010-03-26
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Results First Posted: 2012-08-08
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• Healthy 2 to 6 month-old infant
• Available for entire study period

Exclusion Criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with a pneumococcal conjugate vaccine.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
• Known or suspected immune deficiency or suppression.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series	one month after 3-dose infant series (at 7 months of age)	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series	one mone month after 3-dose infant series (at 7 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.
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 12 - 15 months of age)	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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 Group Relative After the Toddler Dose	one month after the toddler dose (at 12-15 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.