Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
Status and phase
Completed
Phase 3
Conditions
Malaria
Malaria Vaccines
Treatments
Biological: Yellow fever vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Engerix-B™ vaccine
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
705 patients
Sex
All
Ages
8 to 12 weeks old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry:
- 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
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- 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.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
705 participants in 11 patient groups
RTS,S Regimen A Lot 1 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen A Lot 2 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen A Lot 3 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen B Lot 1 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen B Lot 2 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen B Lot 3 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen C Lot 1 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen C Lot 2 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
RTS,S Regimen C Lot 3 Group
Experimental group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
Engerix B Regimen A Group
Active Comparator group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
Engerix B Regimen B Group
Active Comparator group
Description:
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.
Treatment:
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Measles vaccine
Biological: Synflorix™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: Yellow fever vaccine
Biological: Engerix-B™ vaccine
Trial contacts and locations
2
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