Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
Condition: Malaria
MeSH terms: Malaria
Intervention: Malaria Vaccine 257049; Meningococcal C Conjugate Vaccine; Cell-culture rabies vaccine; TritanrixHepB/Hib; Polio Sabin Oral Polio Vaccine (GSK)
Intervention description: administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered orally.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15459.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this observer-blind study is to gather key efficacy, safety, and
      immunogenicity information on GSK's candidate malaria vaccine in infants and children.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry:

          -  A male or female child of:5-17 months (inclusive) of age at time of first
             vaccination,or between 6-12 weeks of age at time of first vaccination and NOT have
             already received a dose of vaccine against diphtheria, tetanus or pertussis or
             Hemophilus influenzae type B and must be > 28 days of age at screening.

          -  Signed informed consent or thumb-printed and witnessed informed consent obtained from
             the parent(s)/guardian(s) of the child.

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

        All subjects must satisfy the following criteria at the start of the extension phase:

          -  Subjects who were enrolled and who received at least one vaccine dose in the primary
             trial phase.

          -  Subjects who were present for Visit 35 on or before 30 September 2013.

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol (e.g. return for follow-up visits) should
             be enrolled in the study.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If any apply, the
        subject must not be included in the study:

          -  Acute disease at the time of enrollment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality.

          -  Anemia associated with clinical signs or symptoms of decompensation or hemoglobin ≥
             5.0 g/dL.

          -  Major congenital defects.

          -  History of allergic reactions, significant IgE-mediated events or anaphylaxis to
             previous immunizations.

          -  Children with a past history of a neurological disorder or atypical febrile seizure.

          -  Children with malnutrition requiring hospital admission.

          -  Children currently meeting the criteria for HIV disease of Stage III or Stage IV
             severity as defined by the World Health Organization.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to a drug or vaccine that is
             not licensed for that indication with the exception of studies with the objective of
             improving the drug treatment or clinical management of severe malaria disease.

          -  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.

          -  Previous participation in any other malaria vaccine trial.

          -  Receipt of a vaccine within the preceding 7 days.

          -  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