480
Participants
Start Date
January 13, 2011
Primary Completion Date
April 30, 2014
Study Completion Date
December 23, 2014
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
Engerix-B
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
GSK Investigational Site, Bangwe, Blantyre
Lead Sponsor
The PATH Malaria Vaccine Initiative (MVI)
OTHER
GlaxoSmithKline
INDUSTRY