Skip to content

Efficacy of pneumococcal conjugate vaccine in preventing acquisition and carriage of pneumococcal vaccine serotypes in Tanzanian children with human immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS)

Efficacy of pneumococcal conjugate vaccine in preventing acquisition and carriage of pneumococcal vaccine serotypes in Tanzanian children withhuman immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000999033
Enrollment
216
Registered
2010-11-17
Start date
2011-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Prof Robert Booy
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

HIV positive children aged 1-14 years old

Exclusion criteria

Previous vaccination

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026