NCT00743652

Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 5 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Conditions

• Pneumococcal Disease
• 13-valent Pneumococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-08-29
• Last updated: 2012-03-15
• Results posted: 2012-02-10

Locations

21 sites across 1 country: United States