Status:
COMPLETED
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Vaccines, Pneumococcal Conjugate Vaccine
Eligibility:
All Genders
28-54 years
Phase:
PHASE3
Brief Summary
The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy 1 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
- Exclusion criteria:
- Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00676091
Start Date
April 1 2008
End Date
September 1 2009
Last Update
August 8 2011
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Curitiba, Brazil, 80060-900
2
Florianópolis, Brazil, 88025-301
3
Sau Paulo, Brazil, 04020-060
4
Sau Paulo, Brazil, 04038-001