NCT00366548

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13 valent pneumococcal conjugate vaccine with Polysorbate 80
BIOLOGICAL	13 valent pneumococcal conjugate vaccine without Polysorbate 80

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-08-21
• Last updated: 2012-08-15
• Results posted: 2012-08-15

Locations

14 sites across 1 country: Poland