NCT00464945

Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 41 Days – 99 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	1 dose at 2,3,4 and 12 months of age

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-04-24
• Last updated: 2012-08-15
• Results posted: 2012-08-15

Locations

9 sites across 1 country: Poland