An extension to study MALARIA-055 PRI to evaluate the long-term efficacy, safety and immunogenicity of GSK Biologicals malaria vaccine in Africa.
Not Applicable
- Conditions
- Malaria
- Registration Number
- PACTR201408000873384
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 4000
Inclusion Criteria
Subjects parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Exclusion Criteria
- Child in care.
- Use of any investigational or non-registered product or planned use during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of severe malaria meeting the primary case definition.
- Secondary Outcome Measures
Name Time Method