RecruitingMalaria
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
Eligible age
0.4–5 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 1. 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.
- ✓ 2. 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).
- ✓ 3. Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
- ✓ 4. Healthy, as established by medical history and clinical examination.
- ✓ 5. Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- ✓ 6. With hemoglobin levels \>8 g/dL.
- ✓ 7. Born after a gestation period of ≥37 weeks.
You may not qualify if…
- ✕ 1. Progressive, unstable, or uncontrolled clinical conditions.
- ✕ 2. History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- ✕ 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- ✕ 4. Clinical conditions representing a contraindication to IM vaccination or blood draws.
- ✕ 5. Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- ✕ 6. Recurrent history of or uncontrolled neurological disorders or seizures.
- ✕ 7. Undernutrition, defined as WHO Z-score less than -2 standard deviation.
- ✕ 8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
Source: ClinicalTrials.gov · NCT07036159 · last updated 2025-09-29