NCT00205803

Study Evaluating Pneumococcal Vaccine in Healthy Infants

A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 249 (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 evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.

Conditions

• Healthy Subjects
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
BIOLOGICAL	7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

Timeline

• Start date: 2004-09-01
• Completion: 2007-05-01
• First posted: 2005-09-20
• Last updated: 2012-08-15
• Results posted: 2012-08-15

Locations

1 site across 1 country: United States