A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

Wyeth is now a wholly owned subsidiary of Pfizer0 sites193 target enrollmentSeptember 2007

ConditionsVaccines, Pneumococcal Conjugate Vaccine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 193
Primary Endpoint: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

August 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series

Time Frame: 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 Outcomes

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))
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))
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))