A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
NCT ID: NCT07036159
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
238 participants
INTERVENTIONAL
2025-08-06
2027-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Groups 1 to 3
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2.
RTS,S/AS01E vaccine
RTS,S/AS01E vaccine will be administered intramuscularly.
Groups 4 and 5
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7.
RTS,S/AS01E vaccine
RTS,S/AS01E vaccine will be administered intramuscularly.
Groups 6 and 7
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7.
RTS,S/AS01E vaccine
RTS,S/AS01E vaccine will be administered intramuscularly.
Interventions
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RTS,S/AS01E vaccine
RTS,S/AS01E vaccine will be administered intramuscularly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
9. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
10. Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
11. Prior receipt of a malaria vaccine (registered or experimental).
12. Use of any investigational or non-registered product (drug, vaccine, or medical device)\* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or planned use during the study period.
\*Use of herbs and traditional treatments is not considered an exclusion criterion.
13. Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration\*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign\*.
\*If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.
14. Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
15. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this means prednisone ≥0.5 mg/kg/day or 20 mg/day, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
16. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
17. Any study personnel's immediate dependents, family, or household members.
18. Child in care.
5 Months
60 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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Julien M Nyombayire, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Center for Family Health Research
Mossi Nzeyimana, MD
Role: PRINCIPAL_INVESTIGATOR
Rinda Ubuzima Gatenga Medicalized Health Center University of Rwanda
Locations
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GSK Investigational Site
Kigali, , Rwanda
GSK Investigational Site
Kigali, , Rwanda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-000563-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
223247
Identifier Type: -
Identifier Source: org_study_id
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