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First Results From Ongoing Phase III Trial Show Malaria Vaccine Candidate, RTS,S* Reduces the Risk of Malaria by Half in African Children Aged 5 to 17 Months
Date:10/18/2011

anging between 0 and 22 months (average 11.5 months).

Long-term efficacyThe RTS,S malaria vaccine candidate is still under development. Further information about the longer-term protective effects of the vaccine, 30 months after the third dose, should be available by the end of 2014. This will provide evidence for national public health and regulatory authorities, as well as international public health organisations, to evaluate the benefits and risks of RTS,S.

SafetyThe overall incidence of serious adverse events (SAEs)** in this trial was comparable between the RTS,S candidate vaccine (18%) recipients and those receiving a control vaccine (22%).

Differences in rates of SAEs were observed between the vaccine groups for specific events, such as seizures and meningitis, and were higher in the malaria vaccine group. Seizures were considered to be related to fever and meningitis was considered unlikely to be vaccine-related. These events will continue to be monitored and additional information about the safety profile of the RTS,S malaria vaccine candidate will become available over the next three years.

Tsiri Agbenyega, a principal investigator of the trial and Chair of the Clinical Trials Partnership Committee, said: "The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S. These results confirm findings from previous Phase II studies and support ongoing efforts to advance the development of this malaria vaccine candidate.  Having worked in malaria research for more than 25 years, I can attest to how difficult making progress against this disease has been. Sadly, many have resigned themselves to malaria being a fact of life in Africa. This need not be the case. Renewed interest in malaria by the international community, and scientific evidence such as that we are reporting today, should bring new hope that malaria can be controlled."

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SOURCE GlaxoSmithKline
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