Safety and immunogenicity of GSK Biologicals’ malaria vaccine 257049 when administered on 7 schedules to African infants

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.

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:

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.