Clinical Trial: Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in
Brief Summary: 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.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- 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. ]
Original Primary Outcome: safety and immunogenicity up to one month post final vaccine dose
Current Secondary Outcome:
- 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. ]
Original Secondary Outcome: reactogenicity, non-inferiority and immunogenicity up to one month post final vaccine dose
Information By: GlaxoSmithKline
Dates:
Date Received: February 16, 2006
Date Started: April 7, 2006
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017