Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
NCT ID: NCT01345240
Last Updated: 2019-07-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
705 participants
INTERVENTIONAL
2011-11-17
2017-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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RTS,S Regimen A Lot 1 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen A Lot 2 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen A Lot 3 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen A, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen A included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen B Lot 1 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen B Lot 2 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen B Lot 3 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen B, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen B included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen C Lot 1 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 1 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 1, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen C Lot 2 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 2 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 2, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
RTS,S Regimen C Lot 3 Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the RTS,S Vaccination Regimen C, with the RTS,S vaccine administered in its Lot 3 formulation. This RTS,S Vaccination Regimen C included 3 doses of RTS,S vaccine, Lot 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Engerix B Regimen A Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Engerix B Regimen B Group
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Interventions
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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.
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.
Infanrix/Hib™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
Polio Sabin™ vaccine
Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
Rotarix™ vaccine
Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
Synflorix™ vaccine
Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
Measles vaccine
Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
Yellow fever vaccine
Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Eligibility Criteria
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Inclusion Criteria
* A male or female infant aged between 8 and 12 weeks inclusive at the time of first vaccination
* Signed or thumb-printed informed consent obtained from the parent(s)/Legally Acceptable Representative \[LAR(s)\] of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness
* Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol
* Healthy subjects as established by medical history and clinical examination before entering into the study
* Born to a mother who is Hepatitis B surface antigen (HBsAg) negative
* Born to a mother who is Human Immunodeficiency Virus (HIV) negative
* Born after a normal gestation period of 36 to 42 weeks inclusive.
Exclusion Criteria
* Child in care
* Acute disease and/or fever at the time of enrolment
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests
* Laboratory screening tests out of range
* Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b, Streptococcus pneumoniae, hepatitis B vaccine or rotavirus vaccines.
* Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
* Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins and/or any blood products in the period between birth and Dose 1 and within the three months preceding planned vaccine administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs in the period between birth and Dose 1.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Same sex twin
* Maternal death
* History of allergic reactions or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
* Any other findings that the investigator feels would result in data collected being incomplete or of poor quality.
* Previous participation in any other malaria vaccine trial.
8 Weeks
12 Weeks
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Ouagadougou, , Burkina Faso
GSK Investigational Site
Kumasi, , Ghana
Countries
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References
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Valea I, Adjei S, Usuf E, Traore O, Ansong D, Tinto H, Owusu Boateng H, Leach A, Mwinessobaonfou Some A, Buabeng P, Vekemans J, Nana LA, Kotey A, Vandoolaeghe P, Ouedraogo F, Sambian D, Lievens M, Tahita MC, Rettig T, Jongert E, Lompo P, Idriss A, Borys D, Ouedraogo S, Prempeh F, Habib MA, Schuerman L, Sorgho H, Agbenyega T. Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial. Hum Vaccin Immunother. 2018 Jun 3;14(6):1489-1500. doi: 10.1080/21645515.2018.1442996. Epub 2018 Apr 13.
Provided Documents
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Document Type: Study Protocol
Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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2011-001508-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
113681
Identifier Type: -
Identifier Source: org_study_id
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