NCT00444457

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,712 (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 will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
BIOLOGICAL	7vPnC	0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-03-07
• Last updated: 2012-10-15
• Results posted: 2010-07-14

Locations

78 sites across 1 country: United States