Last updated: 11/07/2018 13:29:14
Phase IIb controlled randomised double-blind study to evaluate the efficacy, safety and immunogenicity of SmithKline Beecham Biologicals’ candidate RTS,S malaria vaccine in semi-immune adult males in The Gambia.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: Phase IIb controlled randomised double-blind study to evaluate the efficacy, safety and immunogenicity of SmithKline Beecham Biologicals’ candidate RTS,S malaria vaccine in semi-immune adult males in The Gambia.
Trial description: Phase IIb controlled randomised double-blind study to evaluate the efficacy, safety and immunogenicity of SmithKline Beecham Biologicals’ candidate RTS,S malaria vaccine in semi-immune adult males in The Gambia.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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Secondary outcomes:
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Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
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Time perspective:
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Clinical publications:
Alloueche A et al. (2003) Protective efficacy of the RTS,S/AS02 Plasmodium falciparum malaria vaccine is not strain specific. Am J Trop Med Hyg. 68(1):97-101.
Bojang KA et al. (2001) Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet. 358(9297):1927-1934.
Bojang KA et al. (2009) Five-year safety and immunogenicity of GlaxoSmithKline's candidate malaria vaccine RTS,S/AS02 following administration to semi-immune adult men living in a malaria-endemic region of The Gambia. Hum Vaccine. 5(4):242-247.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
February 1998 to December 1999
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-10-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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