NCT00688870

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Vaccines
• Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine (13vPnC)	13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
BIOLOGICAL	7-valent pneumococcal conjugate vaccine (7vPnC)	7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Timeline

• Start date: 2008-06-05
• Primary completion: 2010-01-13
• Completion: 2010-01-13
• First posted: 2008-06-03
• Last updated: 2022-10-07
• Results posted: 2011-05-12

Locations

2 sites across 1 country: Taiwan