Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 30, 2010

Primary Completion Date

May 24, 2013

Study Completion Date

May 24, 2013

Conditions
Malaria
Interventions
BIOLOGICAL

GSK Biological's Investigational Malaria Vaccine 257049

All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.

BIOLOGICAL

Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);

"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"

BIOLOGICAL

Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).

"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."

Trial Locations (2)

Unknown

GSK Investigational Site, Kisian

GSK Investigational Site, Kisumu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY