Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium
falciparum (P. falciparum) malaria vaccine is being developed 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 P. falciparum. The vaccine would also provide
protection against infection with hepatitis B virus (HBV).
This phase IIb trial is being carried out following the demonstration of efficacy of the
candidate malaria 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 this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the
safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period
commencing 21 months after Dose 1.
This protocol posting deals with objectives & outcome measures of the extension phase at year
2. During this extension study, no new subjects will be recruited and no vaccine will be
administered.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.