Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
Intervention description: 4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 5 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Malaria; Plasmodium falciparum

Summary:

      The purpose of this study is to show the consistency of different lots of a candidate vaccine
      (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  A male or female child between, and including, 5 and 17 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
             child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned
             by a witness.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects who have received three documented doses of hepatitis B vaccine.

        Exclusion Criteria:

          -  Same sex twins.

          -  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.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Moderate or severe malnutrition at screening defined as weight for age Z-score less
             than 2.

          -  Acute disease and/or fever at the time of enrolment

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or medical history.

          -  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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/administration of a licensed vaccine not foreseen by the study
             protocol within 7 days of the first dose of study 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 an investigational or a
             non-investigational product.

          -  Administration of immunoglobulins and/or any blood products within 1 month preceding
             the first dose of study vaccine or planned administration during the study period.

          -  Child in care.

          -  Any other findings that the investigator feels would increase the risk of having an
             adverse outcome from participation in the trial.