At a glance
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Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa
In Brief
A Phase 2 clinical trial evaluating GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B, and 4 other interventions for Malaria. Completed, enrolled 480 participants across 1 site.
Detailed Summary
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to: * Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen. * Investigate how to maximize the antibody response to the experimental malaria vaccine.
Study Details
Timeline
Interventions
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age