GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
3-dose intramuscular injection, 2 different formulations
GSK Investigational Site
Lambaréné, Gabon
Occurrence of SAEs.
Time frame: From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).
Time frame: One month post Dose 3.
Occurrence of solicited general and local reactions.
Time frame: Over a 7-day follow-up period after each vaccination.
Occurrence of unsolicited symptoms.
Time frame: After each vaccination over a 30-day follow-up
Anti-CS antibody titers.
Time frame: Prior to vaccination, one month post Dose 2
Anti-Hepatitis B surface agent (anti-HBs) antibody titers.
Time frame: Prior to vaccination, one month post Dose 2 and one month post Dose 3.
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