NCT00289185

Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants

A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Accepted

Summary

GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 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 Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV). In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D when co-administered with a multivalent DTPw/Hib (Aventis Pasteur's TETRActHib vaccine). Infants randomized to the control group will receive a licensed hepatitis B vaccine, Engerix-B in place of RTS,S/AS02D. Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner; data relating to TETRActHib will be collected in an open fashion. Oral polio vaccine (OPV) will be administered at birth, 8, 12, 16 weeks in co-administration with other vaccines and will not be administered as part of this protocol. Antibody titers to OPV will not be assessed as part of this protocol.

Conditions

• Malaria
• Malaria Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	RTS,S/AS02D	3-dose intramuscular injection in the thigh
BIOLOGICAL	Engerix-B®	3-dose intramuscular injection in the thigh.
BIOLOGICAL	TETRActHib™	3-dose intramuscular injection in the thigh.

Timeline

• Start date: 2006-09-27
• Primary completion: 2008-02-11
• Completion: 2009-01-15
• First posted: 2006-02-09
• Last updated: 2020-10-29
• Results posted: 2013-07-08

Locations

1 site across 1 country: Tanzania