Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.
Condition: Malaria; Malaria Vaccines
MeSH terms: Malaria; Rubella; Yellow Fever
Intervention: Vitamin A; Candidate Plasmodium falciparum malaria vaccine; MR-Vac; Stamaril
Intervention description: Oral administration of Vitamin A (1 dose); Intramuscular administration of SB257049 vaccine (4 doses); Subcutaneous injection of a combined measles and rubella vaccine (1 dose); Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
Intervention MeSH terms: Vitamin A; Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 699.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Infants; SB257049; Malaria; Immunogenicity; Surveillance; Efficacy; Safety; Africa; Plasmodium falciparum

Summary:

      The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the
      SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and
      yellow fever vaccines to children aged 6 months at the first vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion
             of the investigator, could and complied with the requirements of the protocol.

          -  A male or female 6 months of age (from the day the child becomes 6 months of age until
             the day before the child achieved 7 months of age) at the time of the first
             vaccination.

          -  Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the
             subject. Where parent(s)/LAR(s) were illiterate, the consent form was countersigned by
             an independent witness.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously received three documented doses of diphtheria, tetanus, and whole-cell
             pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine
             and, if locally recommended, pneumococcal and rotavirus vaccines.

        Exclusion Criteria:

          -  Child in care

          -  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.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose. For corticosteroids, this meant
             prednisone≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids were allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting seven days before the first dose of SB257049 measles, rubella
             and YF vaccines and ending 42 days after the last dose of vaccines given at 9 months
             of age (Visit 4), with the exception of oral polio vaccine which could be given for
             unforeseen public health threat.

          -  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 vaccine/product.

          -  Previous vaccination against measles, YF or rubella.

          -  Previous administration of Vitamin A.

          -  Moderate or severe malnutrition at screening defined as weight for age Z-score < -2.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s). See also Section 1.3.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment. Fever was defined as temperature
             ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal
             route. The preferred route for recording temperature in this study was axillary.

        Subjects with a minor illness without fever might have been enrolled at the discretion of
        the investigator.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Same sex twin.

          -  Maternal death.

          -  Previous participation in any other malaria study.