drugset / Trial / NCT00170612

Pneumococcal Vaccination of Fiji Infants

NCT00170612

RandomizedParallel-groupOpen-labelPrevention

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 around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.

Timeline

Start
2005-11
Primary completion
2008-01
Completion
2008-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Pneumovax 23 Vaccine 25 ug
Subject Pneumovax 23 Vaccine 20 %
Subject Prevnar 13 Vaccine 2 ug
Subject Prevnar 13 Vaccine 4 ug