A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
ConditionMalaria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-60
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Progressive, unstable, or uncontrolled clinical conditions.
History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Clinical conditions representing a contraindication to IM vaccination or blood draws.
Trial design
Treatments tested in this trial
- RTS,S/AS01E vaccine
Treatment groups
238 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov