Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Rabipur
Intervention description: 2 different formulations are tested. For each formulation, 3 different dosing schedules are tested; 3-dose intramuscular injection.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 540.0
Sex: All
Minimum age: 5 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Prophylaxis Plasmodium falciparum malaria; Plasmodium falciparum; Malaria

Summary:

      This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines
      administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian
      children. The Protocol Posting has been updated in order to comply with the FDA Amendment
      Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child between 5 months and 17 months of age at the time of first
             vaccination.

          -  Written or oral, signed 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.

          -  Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in
             infancy.

        Exclusion Criteria:

          -  Acute disease at the time of enrolment.

          -  Serious acute or chronic illness determined by clinical or physical examination and
             laboratory screening tests.

          -  Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and
             creatinine out of acceptable limits.

          -  Planned administration/administration of a vaccine (not in the scope of the study)
             within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or
             scheduled Yellow fever or Measles vaccine.

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the first dose of the study vaccine, or planned use
             during the study period.

          -  Administration of immunoglobulins, blood transfusions or other blood products within
             the three months preceding the first dose of study vaccine or planned administration
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Simultaneous participation in any other clinical trial;

          -  Previous participation in any other malaria vaccine trial;

          -  Any twins

          -  History of allergic reactions (significant IgE-mediated events) 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.