A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, Administered Intramuscularly According to a 0, 1 and 2 Month Vaccination Schedule in Toddlers and Children Aged 1 to 4 Years in a Malaria-endemic Region of Mozambique.

Malaria is an important cause of death and serious illness among Mozambican children. Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be helpful if children could be protected against malaria by a vaccine. GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum and also would provide protection against infection with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02 to be safe when administered in adults and children aged 1-11 years. However, to assess if this vaccine could provide protection against malaria in children, this study has been undertaken.

疟疾是莫桑比克儿童死亡及重症疾患的重要致病因素。尽管通过药物与浸渍蚊帐可降低疟疾感染风险，但若能借助疫苗为儿童提供疟疾防护，将具备极高的公共卫生价值。葛兰素史克生物制品公司（GSK Biologicals）正与PATH旗下疟疾疫苗倡议组织（Malaria Vaccine Initiative）合作开发候选疟疾疫苗RTS,S/AS02，用于疟疾流行地区婴幼儿及儿童的常规免疫接种。该疫苗不仅可抵御由恶性疟原虫（Plasmodium falciparum）引发的疟疾，还能预防乙型肝炎病毒（hepatitis B virus）感染。既往研究表明，候选疟疾疫苗RTS,S/AS02在成人及1-11岁儿童中接种时安全性良好。然而，为评估该疫苗能否为儿童提供疟疾防护，本研究已正式开展。