Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT07036159
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-000563-20 | EUDRACT_NUMBER | None | View |