• First case of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months ] [ Designated as safety issue: No ]
• Multiple events of malaria meeting the primary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ] [ Designated as safety issue: No ]
• Multiple events of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ] [ Designated as safety issue: No ]
• Parasite prevalence and density [ Time Frame: At 4½ months post Dose 3 ] [ Designated as safety issue: No ]
• Haemoglobin [ Time Frame: At 4½ months post Dose 3. ] [ Designated as safety issue: No ]
• Occurrence of solicited symptoms and local reactions. [ Time Frame: Over a 7-day follow-up period ] [ Designated as safety issue: No ]
• Occurrence of unsolicited symptoms. [ Time Frame: Over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination. ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events [ Time Frame: From the time of first vaccination (Month 0) until 4½ months post Dose 3 (Month 6½). ] [ Designated as safety issue: No ]
• Occurrence of parameters of hematological monitoring outside acceptable ranges. [ Designated as safety issue: No ]
• Antibody to the P. falciparum circumsporozoite (CS) repeat domain (anti-CS antibody) titers. [ Time Frame: Prior to vaccination, 1 month post Dose 3 and 4½ months post Dose 3 ] [ Designated as safety issue: No ]
• Anti-hepatitis B surface antigen (anti-HBs) titers [ Time Frame: Prior to vaccination and 1 month post Dose 3. ] [ Designated as safety issue: No ]
• Frequency of CD4+ and CD8+ CS-specific T-cells expressing at least 2 of the following: IL-2, CD40L, TNF-α and IFN-у. [ Time Frame: Prior to vaccination and 1 month post Dose 3. ] [ Designated as safety issue: No ]

• First case of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months ]
• Multiple events of malaria meeting the primary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ]
• Multiple events of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ]
• Parasite prevalence and density [ Time Frame: At 4½ months post Dose 3 ]
• Haemoglobin [ Time Frame: At 4½ months post Dose 3. ]
• Occurrence of solicited symptoms and local reactions. [ Time Frame: Over a 7-day follow-up period ]
• Occurrence of unsolicited symptoms. [ Time Frame: Over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination. ]
• Occurrence of serious adverse events [ Time Frame: From the time of first vaccination (Month 0) until 4½ months post Dose 3 (Month 6½). ]
• Occurrence of parameters of hematological monitoring outside acceptable ranges.
• Antibody to the P. falciparum circumsporozoite (CS) repeat domain (anti-CS antibody) titers. [ Time Frame: Prior to vaccination, 1 month post Dose 3 and 4½ months post Dose 3 ]
• Anti-hepatitis B surface antigen (anti-HBs) titers [ Time Frame: Prior to vaccination and 1 month post Dose 3. ]
• Frequency of CD4+ and CD8+ CS-specific T-cells expressing at least 2 of the following: IL-2, CD40L, TNF-α and IFN-у. [ Time Frame: Prior to vaccination and 1 month post Dose 3. ]

This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Biological: GSK malaria vaccine 257049 Vaccine
• Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine

Inclusion Criteria:

• A male or female child of between 5 months and 17 months of age at the time of first vaccination.
• Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child..
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

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 for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
• Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
• 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 within the three months preceding 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 6 months prior to the first vaccine dose
• Previous participation in any other malaria vaccine trial.
• Simultaneous participation in any other clinical trial.
• Same sex twin.
• 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.