Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
Condition: Malaria; Malaria Vaccines
MeSH terms: Hepatitis B; Malaria; Hepatitis
Intervention: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Engerix-B™ vaccine; Infanrix/Hib™ vaccine; Polio Sabin™ vaccine; Rotarix™ vaccine; Synflorix™ vaccine; Measles vaccine; Yellow fever vaccine
Intervention description: Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.; 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.; Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection; Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.; Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.; Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.; Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.; Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 705.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Africa; Plasmodium falciparum; Malaria vaccine; hepatitis B; EPI

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.
    

Eligibility criteria:

        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.