Last updated: 11/07/2018 13:29:53
A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4
Trial description: A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Macete E et al. (2007) Safety, reactogenicity and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in children aged 1 to 4 years in Mozambique. Trop. Med. Int. Health. 12 (1):37-46.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
June 2002 to October 2002
Type
Not applicable
Phase
1
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
Clinical study report
Available language(s): English
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
2002-11-10
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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Access to clinical trial data by researchers
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