NCT00373958

Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-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: 666 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Conditions

• Vaccines, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	13 valent pneumococcal conjugate vaccine	1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
BIOLOGICAL	7vPnc pneumococcal conjugate vaccine	1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-09-08
• Last updated: 2013-02-21
• Results posted: 2013-02-21

Locations

37 sites across 1 country: United States