Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK Biological's Investigational Malaria Vaccine 257049; Engerix-B; Tritanrix HepB Hib; BCG; OPV; Rouvax
Intervention description: 3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age; 1 dose, intramuscular route: left antero-lateral thigh at birth (=< 7 days of age); 3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age; 1 dose, intradermal route, in shoulder at birth (=< 7 days of age); 4 doses, orally, at birth (=< 7 days of age) and at 6, 10 and 14 weeks of age; 1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 480.0
Sex: All
Minimum age: 1 Day
Maximum age: 7 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Africa; malaria vaccine; schedule; EPI; Plasmodium falciparum

Summary:

      The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an
      efficacious malaria vaccine that is deliverable through the existing system, the Expanded
      Program on Immunization (EPI) of WHO. This study has been designed to:

        -  Investigate the safety and immunogenicity of 7 infant immunization schedules of the
           experimental malaria vaccine integrated with an EPI regimen.

        -  Investigate how to maximize the antibody response to the experimental malaria vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry:

          -  A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of
             birth).

          -  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 the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol (e.g. return for follow-up visits) should
             be enrolled in the study.

          -  Born to a mother negative for HIV antibody and Hepatitis B surface antigen.

          -  Subjects who are born after a normal gestation period (between 37 and 42 weeks)
             (Gestational age will be determined by carrying out a clinical assessment on infants
             according to the principles set out by Dubowitz (1970) in the first 5 days of life).

          -  A minimum weight of 2.5 kg.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If any apply, the
        subject must not be included in the study:

          -  Acute or chronic illness determined by clinical or physical examination and laboratory
             screening tests including, but not limited to:

               -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based
                  on medical history and physical examination.

               -  A family history of congenital or hereditary immunodeficiency.

               -  Major congenital defects.

               -  History of any neurological disorders or seizures.

          -  Laboratory screening tests out of normal ranges/limits defined per protocol.

          -  Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular),
             Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio
             vaccines.

          -  Planned administration/administration of a licensed vaccine (i.e. a vaccine that is
             approved by one of the following authorities: FDA or EU member state or WHO [with
             respect to prequalification]) not foreseen by the study protocol within 7 days of the
             first dose of study vaccine.

          -  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.

          -  Use of a drug or vaccine that is not approved for that indication (by one of the
             following authorities: FDA or EU member state or WHO [with respect to
             prequalification]) other than the study vaccine starting at birth or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Simultaneous participation in any other clinical trial.

          -  Same-sex 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.

          -  Children will not be enrolled if any maternal, obstetrical or neonatal event that has
             occurred might, in the judgment of the investigator, result in increased
             neonatal/infant morbidity

          -  Any other findings that the investigator feels would increase the risk of having an
             adverse outcome from participation in the trial.