None listed
Conditions
Brief summary
This is a randomised controlled trial of a pneumococcal conjugate vaccine to examine the efficacy of this vaccine in preventing the nasopharyngeal acquisition and carriage of vaccine serotypes of pneumococcus, among Tanzanian children with HIV/AIDS. Prevention of nasopharyngeal carriage can be used as a surrogate for vaccine protective efficacy.
Interventions
Pneumococcal vaccination 1 a) containing two microgram of Pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F, and four micrograms of pneumococcal polysaccharide serotype 6B. It also contains sodium chloride and water for injections. b) two identical vaccines will be administered three months apart. c) administered as a intramuscular injection 2 At the fourth visit to the clinic children will be given the first dose of the vaccine they have not yet received. That is children will be given four vaccinations over nine months. Firstly two doses of either control or intervention vaccine then two doses of the other vaccine in succession. There is three months between the final dose of the first type of vaccine and the first dose of the second, there is not usually a wash out in these studies. Children will be randomly allocated to receive control or treatment vaccine first. All children in the study will receive both vaccines only the order will vary.
Sponsors
Study design
Eligibility
Inclusion criteria
HIV positive children aged 1-14 years old
Exclusion criteria
Previous vaccination