A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN

Wyeth is now a wholly owned subsidiary of Pfizer2 sites in 1 country168 target enrollmentJune 5, 2008

ConditionsVaccines Pneumococcal Conjugate Vaccine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Vaccines
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 168
Locations: 2
Primary Endpoint: Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.

Registry

clinicaltrials.gov

Start Date

June 5, 2008

End Date

January 13, 2010

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy 2-month-old infants (42 to 98 days)
•Available for the entire study period (14 months)

Exclusion Criteria

•Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
•A previous anaphylactic reaction to any vaccine or vaccine-related component.

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.

Time Frame: 1 month after the infant series (7 months of age)

Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (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

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose(1 month after toddler dose (16 months of age))