Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
Condition: Malaria; Malaria Vaccines
MeSH terms: Malaria
Intervention: RTS,S/AS02D; Engerix-B®; TETRActHib™
Intervention description: 3-dose intramuscular injection in the thigh; 3-dose intramuscular injection in the thigh.; 3-dose intramuscular injection in the thigh.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coccidiosis; Parasitic Diseases; Malaria, Falciparum; Malaria

Summary:

      GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a
      candidate malaria vaccine GSK 257049 for the routine immunization of infants and children
      living in malaria endemic areas. The vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum. The vaccine would also provide protection against
      infection with hepatitis B virus (HBV).

      In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a
      new variant RTS,S/AS02D (0.5 mL dose) has been developed.

      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 infant between 6 and 10 weeks 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 (e.g. return for follow-up visits).

          -  Born to a mother who is HBsAg negative & HIV negative.

          -  Born after a normal gestation period (between 36 and 42 weeks).

          -  Subjects who live within a 5 km radius of a dispensary.

        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 out of range for haemoglobin, total white cell count,
             platelets, ALT and creatinine.

          -  Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular),
             Hemophilus influenzae type b or hepatitis B vaccines.

          -  BCG administration within one week of proposed administration of a study vaccine.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of vaccine(s).

          -  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 of immunosuppressants or other immune-modifying drugs within
             six 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.

          -  Maternal death.

          -  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.