Status:
COMPLETED
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
13-valent Pneumococcal Vaccine
Eligibility:
All Genders
42-5 years
Phase:
PHASE3
Brief Summary
This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Eligibility Criteria
Inclusion
- Male or female infants 6 weeks to \< 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
- Infants who have received Prevnar are eligible to participate, but this is not required.
- Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)
Exclusion
- Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00743652
Start Date
January 1 2009
End Date
September 1 2010
Last Update
March 15 2012
Active Locations (21)
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1
Pfizer Investigational Site
Akiak, Alaska, United States, 99552
2
Pfizer Investigational Site
Bethel, Alaska, United States, 99559
3
Pfizer Investigational Site
Chefornak, Alaska, United States, 99561
4
Pfizer Investigational Site
Chevak, Alaska, United States, 99563