Status:
COMPLETED
Pneumococcal Vaccination of Fiji Infants
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
Brief Summary
Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection a...
Detailed Description
This research project began as a study of alternative strategies for Pnc (Pneumococcus) immunization for children in developing countries. In the original study, infants presenting to a health center ...
Eligibility Criteria
Inclusion
- Healthy infant aged between 6 and 8 weeks
- No significant maternal or perinatal history
- Written and signed parental/caregiver consent
- Lives within 30 minutes of the health clinic
- Family anticipate living in the study area for the next 2 years
Exclusion
- Known allergy to any component of the vaccine
- Allergic reaction or anaphylactoid reaction with previous vaccines
- Known immunodeficiency disorder
- HIV positive mother (many women are tested for HIV antenatally, however a test is not planned; therefore it would be based on clinic records or self report)
- Known thrombocytopenia or coagulation disorder
- On immunosuppressive medication
- Received any blood product since birth
- Severe congenital anomaly
- Chronic or progressive disease
- Seizure disorder
- History of invasive Pneumococcal, meningococcal, or Haemophilus influenzae diseases
- Moderate or severe acute infection (temporary exclusion); Minor illnesses such as an uncomplicated upper respiratory tract infection, localized skin infections, or mild diarrhea will not be an exclusion criterion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT00170612
Start Date
November 1 2005
End Date
August 1 2008
Last Update
October 21 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Colonial War Memorial Hospital
Suva, Fiji