At a glance
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Safety and Immunogenicity Study of GSK Biologicals' Plasmodium Falciparum Malaria Vaccine 257049 Administered to HIV Infected Infants and Children
In Brief
A Phase 3 clinical trial evaluating GSK Biological's Investigational Malaria Vaccine 257049, Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);, and 1 other intervention for Malaria. Completed, enrolled 200 participants across 2 sites.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
Study Details
Timeline
Interventions
All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.
To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product. The vaccine will be administered intramuscularly
To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product. The vaccine will be administered intramuscularly.