Status:
COMPLETED
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
42-9 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and...
Eligibility Criteria
Inclusion
- 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
- Child in care.
- Use of any investigational or non-registered product or planned use during the study period.
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
3084 Patients enrolled
Trial Details
Trial ID
NCT02207816
Start Date
September 18 2014
End Date
January 31 2017
Last Update
November 25 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Ouagadougou, Burkina Faso
2
GSK Investigational Site
Kisumu, Kenya
3
GSK Investigational Site
Tanga, Tanzania