At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity Study of GSK Biologicals' Investigational Vaccination Regimen Malaria Vaccine 257049, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes Tritanrix HepB/Hib, OPV, Measles and Yellow Fever Vaccination in Infants
In Brief
A Phase 2 clinical trial evaluating GSK 257049, Tritanrix™ HepB/Hib, and 3 other interventions for Malaria. Completed, enrolled 511 participants across 3 sites in 3 countries.
Detailed Summary
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine
GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)
Aventis Pasteur's attenuated measles vaccine.
Aventis Pasteur's attenuated yellow fever vaccine.
GSK Biologicals' oral polio virus vaccine