At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
In Brief
A Phase 3 clinical trial evaluating GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, and 6 other interventions for Malaria and Malaria Vaccines. Completed, enrolled 705 participants across 2 sites in 2 countries.
Detailed Summary
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.
Study Details
Timeline
Interventions
Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.