Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
Condition: Malaria
MeSH terms: Malaria
Intervention: RTS,S/AS02D; TETRActHib™; Engerix-B®
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: 214.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      GSK Biologicals is developing in partnership with the Program for Appropriate Technology in
      Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine 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).

      This trial is being carried out following the demonstration of efficacy of a previous version
      of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated
      approximately 30% efficacy against clinical episodes of malaria and approximately 58%
      efficacy against severe malaria disease.

      In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI)
      regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine 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 of between 6 and 12 weeks of age at the time of first
             vaccination.

          -  Written informed consent obtained from the parent(s) or guardian(s) of the subject

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Born to a mother who is hepatitis B surface antigen (HBsAg) negative and human
             immunodeficiency virus (HIV) negative.

          -  Born after a normal gestation period (between 36 and 42 weeks).

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

        Exclusion Criteria:

          -  Bacillus Calmette-Guérin tuberculosis vaccine (BCG) administration within one week of
             proposed administration of a study vaccine.

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth

          -  Any chronic drug therapy to be continued during the study period.

          -  Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type
             b or hepatitis B vaccines.

          -  Major congenital abnormality.

          -  Serious acute or chronic illness determined by clinical, physical examination and
             laboratory screening tests

          -  Any medically diagnosed or suspected immunodeficient condition based on medical
             history and physical examination

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  History of any neurological disorders or seizures.

          -  Maternal death.

          -  Hemoglobin < 80 g/L

          -  Simultaneous participation in any other clinical trial.

          -  Same sex twin

          -  Any other findings that the investigator feels would increase the risk of having an
             adverse outcome from participation in the trialModerate malnutrition at screening