Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT03855995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2019-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Prospective Study to Evaluate the Safety, Effectiveness and Impact of the RTS, S/AS01E Vaccine in Young Children in Sub-Saharan Africa
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
EPI-MAL-003
Brief Summary:
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced. Along with safety, researchers will also assess how well the vaccine works and its overall impact on children's health.
Detailed Description:
This is a disease surveillance study with prospective cohort event monitoring including both temporal and concurrent comparisons of the occurrence of adverse and malaria events between vaccinated and unvaccinated subjects living in exposed or unexposed clusters located in sub-Saharan Africa (SSA) countries, and eligible for RTS,S/AS01E vaccination for those living in the exposed clusters. The design includes active surveillance and enhanced hospitalization surveillance in both exposed and unexposed clusters.
The study targeted enrolling at least 45,000 children in active surveillance, including 22,500 in the exposed clusters and 22,500 in the unexposed clusters for evaluation of the vaccine safety, effectiveness, and impact.
All data analyses will be computed in a descriptive manner. Data regarding the hospitalization will be uniformly collected whether the child is enrolled in active surveillance or in enhanced hospitalization surveillance.
The study targeted enrolling at least 45,000 children in active surveillance, including 22,500 in the exposed clusters and 22,500 in the unexposed clusters for evaluation of the vaccine safety, effectiveness, and impact.
All data analyses will be computed in a descriptive manner. Data regarding the hospitalization will be uniformly collected whether the child is enrolled in active surveillance or in enhanced hospitalization surveillance.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: