Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

January 13, 2011

Primary Completion Date

April 30, 2014

Study Completion Date

December 23, 2014

Conditions
Malaria
Interventions
BIOLOGICAL

GSK Biological's Investigational Malaria Vaccine 257049

3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age

BIOLOGICAL

Engerix-B

1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)

BIOLOGICAL

Tritanrix HepB Hib

3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age

BIOLOGICAL

BCG

1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)

BIOLOGICAL

OPV

4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age

BIOLOGICAL

Rouvax

1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age

Trial Locations (1)

3

GSK Investigational Site, Bangwe, Blantyre

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT01231503 - Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants | Biotech Hunter | Biotech Hunter