This trial seeks to determine a safe and effective vaccination regimen for Fiji, using a lesser number of pneumococcal conjugate vaccine doses accompanied by plain 23-valent pneumococcal polysaccharide vaccine to broaden the immune response.

Condition	Intervention	Phase
Pneumococcal Infections	Vaccine: Pneumovax 23  Vaccine: Prevnar	Phase II

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Expected Total Enrollment:  550

Pnc is the most common cause of bacterial OM, pneumonia, bacteremia, and meningitis in children worldwide.In developing countries, an estimated 1 million deaths/year of children < 5 years are attributable to Pnc disease. The case fatality rate is particularly high in infants < 6 months old. This study is an open, randomized, phase 2 study involving 550 infants to determine the safety, immunogenicity and qualitative function of Pnc antibodies following different regimens of Pnc conjugate vaccination.

Ages Eligible for Study:  6 Weeks   -   8 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Healthy infant aged between 6 and 8 weeks
2. No significant maternal or perinatal history
3. Written and signed parental/caregiver consent
4. Lives within 30 minutes of the health clinic
5. Family anticipate living in the study area for the next 2 years

Exclusion Criteria:

1. Known allergy to any component of the vaccine
2. Allergic reaction or anaphylactoid reaction with previous vaccines
3. Known immunodeficiency disorder
4. HIV positive mother (many women are tested for HIV antenatally, however we do not plan to test; therefore it would be based on clinic records or self report)
5. Known thrombocytopenia or coagulation disorder
6. On immunosuppressive medication
7. Received any blood product since birth
8. Severe congenital anomaly
9. Chronic or progressive disease
10. Seizure disorder
11. History of invasive Pnc, meningococcal, or Haemophilus influenzae diseases
12. 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00170612

Fiona Russell      +61 3 8344 2000 

Fiji
      Colonial War Memorial Hospital, Suva,  Fiji
      Fiji School of Medicine, Suva,  Fiji

Study ID Numbers:  03-042; FNRERC Reference #: 2002-001
Last Updated:  December 22, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00170612
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10