At a glance
ClinicalIndex Comparison Record- ✓Male or female infant between 6 and 12 weeks of age at first vaccination
- ✓Free of obvious health problems by medical history and clinical examination
- ✓Born to a mother who is HBsAg negative and HIV negative
- ✓Born after normal gestation period (36-42 weeks)
- ✕BCG vaccine administered within one week of proposed study vaccine administration
- ✕Use of investigational or non-registered drug or vaccine within 30 days before first dose
- ✕Administration of immunoglobulins or blood products since birth or planned during study
- ✕Chronic immunosuppressants or immune-modifying drugs (>14 days) since birth
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine in Infants Living in a Malaria-endemic Region
In Brief
A Phase 2 clinical trial evaluating RTS,S/AS02D, TETRActHib™, and 1 other intervention for Malaria. Completed, enrolled 214 participants across 1 site.
Detailed Summary
GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV). This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI) regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
3-dose intramuscular injection in the thigh
3-dose intramuscular injection in the thigh.
3-dose intramuscular injection in the thigh.