Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK malaria vaccine 257049 Vaccine; Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine
Intervention description: 3 dose intramuscular injection; 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: 894.0
Sex: All
Minimum age: 5 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Malaria; Plasmodium; RTS; S/AS01; Falciparum

Summary:

      This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent
      children from falling ill with malaria and to evaluate vaccine safety.

      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 of 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.

        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 foreseen by the study within 30
             days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled
             diphtheria, pertussis or measles vaccine.

          -  Use of any investigational or non-registered drug or vaccine within 30 days preceding
             the first dose of 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 (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to the first vaccine dose

          -  Previous participation in any other malaria vaccine trial.

          -  Simultaneous participation in any other clinical trial.

          -  Same sex twin.

          -  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.