Status:
COMPLETED
Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Vaccines, Pneumococcal
Eligibility:
All Genders
42-98 years
Phase:
PHASE3
Brief Summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
Eligibility Criteria
Inclusion
- Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
- Able to complete three blood draws during study
- At least 3.5 kg at enrollment
Exclusion
- Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
- Immune deficiency, bleeding disorder or significant chronic medical condition
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00708682
Start Date
July 1 2008
End Date
May 1 2010
Last Update
October 25 2011
Active Locations (9)
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1
Guadalajara, Jalisco, Mexico, 44080
2
Distrio Federal, Mexico, Mexico, 14080
3
Distrio Federal, Mexico, Mexico, 4530
4
Morelia, Michoacán, Mexico, 58070