A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S/AS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
• Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.
• Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).
• Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
• Healthy, as established by medical history and clinical examination.
• Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
• With hemoglobin levels \>8 g/dL.
• Born after a gestation period of ≥37 weeks.