NCT01345240

Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 705 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

Conditions

• Malaria
• Malaria Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049	Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
BIOLOGICAL	Engerix-B™ vaccine	Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
BIOLOGICAL	Infanrix/Hib™ vaccine	Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
BIOLOGICAL	Polio Sabin™ vaccine	Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
BIOLOGICAL	Rotarix™ vaccine	Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
BIOLOGICAL	Synflorix™ vaccine	Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
BIOLOGICAL	Measles vaccine	Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
BIOLOGICAL	Yellow fever vaccine	Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.

Timeline

• Start date: 2011-11-17
• Primary completion: 2013-01-09
• Completion: 2017-02-09
• First posted: 2011-05-02
• Last updated: 2019-07-18
• Results posted: 2014-02-10

Locations

2 sites across 2 countries: Burkina Faso, Ghana