Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry:

• A male or female infant or child between and including 6 weeks to 17 months of age, atthe time of first vaccination.

• Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of theinfant or child. Where parents/LARs are illiterate, the consent form will becountersigned by a witness.

• Subjects who the investigator believes that their parents/LARs can and will complywith the requirements of the protocol should be enrolled in the study.

• Subjects who are known to be HIV-infected (documented positive DNA PCR), whethertaking HIV antiretroviral treatment (ART) or not.

• Subjects who are born following a normal gestation period.

Exclusion Criteria: The following criteria should be checked at the time of study entry. If ANY exclusioncriterion applies, the subject must not be included in the study:

• Acute disease at the time of enrolment. However, the presence of an illness listed asGrade I or Grade II (WHO pediatric AIDS clinical staging) will not of itselfconstitute an exclusion criterion. Enrolment should be deferred if axillarytemperature is >=37.5°C.

• Grade III or Grade IV abnormality on screening laboratory blood sample.

• Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).

• Major congenital defects.

• Planned administration/administration of a vaccine not foreseen by the study protocolprior to or within 7 days of study vaccine.

• Use of any investigational or non-registered product (drug or vaccine) other than thestudy vaccine 30 days preceding Dose°1 of study vaccine, or planned use during thestudy period.

• Previous participation in any other malaria vaccine trial.

• Simultaneous participation in another clinical trial including administration ofexperimental treatment.

• Same sex twins.

• History of allergic reactions (significant IgE-mediated events) or anaphylaxis toprevious immunizations.

• History of allergic disease or reactions likely to be exacerbated by any component ofthe study vaccine.

• Child in care.