Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK 257049; Tritanrix™ HepB/Hib; Rouvax™; Stamaril™; Polio Sabin™
Intervention description: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine; GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™); Aventis Pasteur's attenuated measles vaccine.; Aventis Pasteur's attenuated yellow fever vaccine.; GSK Biologicals' oral polio virus vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 511.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Africa; Plasmodium falciparum; Malaria

Summary:

      This study is being done to assess the possibility of the potential integration of malaria
      vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and
      immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI
      vaccine antigens. 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.

          -  Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of
             the child. Where parent(s)/guardian(s) are illiterate, the consent form will be
             countersigned by a witness.

          -  Subjects who have received one previous dose of OPV and BCG.

          -  Subjects who are born after a normal gestation period (between 36 and 42 weeks).

        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, specifically: ALT and creatinine above
             acceptable limit; Hemoglobin, Platelet count and Total white cell count below
             acceptable limit.

          -  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.

          -  OPV administration within four weeks 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 since
             birth to 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 six months prior to the first vaccine dose.

          -  Simultaneous participation in any other clinical trial.

          -  Twins (to avoid misidentification).

          -  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.