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NCT03162614 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
A Phase 2 study of Malaria, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT03162614 is a Phase 2 study of Malaria that has completed, run by GlaxoSmithKline. The registered enrollment target is 154 participants, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03162614, a Phase 2 study of Malaria, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to investigate whether changes in dosing schedule are associated with increased or equivalent protection, and to evaluate the immune mechanisms associated with vaccine efficacy under varying dosing schedules.
Conditions Studied
Interventions
- BIOLOGICAL RTS,S/AS01E
- BIOLOGICAL RTS,S/AS01B
- PROCEDURE Sporozoite-infected mosquitoes challenge.
Study Locations (1)
Maryland
- GSK Investigational Site - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03162614
The ClinicalTrials.gov registry entry for NCT03162614 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 3 interventions - of which RTS,S/AS01E is the first listed.
NCT03162614 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03162614 about?
NCT03162614 is a clinical study titled "Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults". This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to ...
What is the current status of trial NCT03162614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2017-05-24. Estimated completion is 2018-09-24.
What conditions does trial NCT03162614 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT03162614?
The interventions under investigation include: RTS,S/AS01E (BIOLOGICAL), RTS,S/AS01B (BIOLOGICAL), Sporozoite-infected mosquitoes challenge. (PROCEDURE).
Who is sponsoring clinical trial NCT03162614?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162614 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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