Trials / Recruiting
RecruitingNCT07036159
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 5 Months – 60 Months
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RTS,S/AS01E vaccine | RTS,S/AS01E vaccine will be administered intramuscularly. |
Timeline
- Start date
- 2025-08-06
- Primary completion
- 2027-04-23
- Completion
- 2027-04-23
- First posted
- 2025-06-25
- Last updated
- 2025-09-29
Locations
2 sites across 1 country: Rwanda
Source: ClinicalTrials.gov record NCT07036159. Inclusion in this directory is not an endorsement.