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NCT03824236 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03824236 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants.
The verdict
NCT03824236, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study (follow-up to MALARIA-092 \[NCT03162614\] study) is to evaluate if protection can be extended with an additional Fx booster dose and if unprotected subjects can be protected following a Fx booster dose. In this booster study, subjects from MALARIA-092 (NCT03162614) study who completed vaccination and challenge will receive a Fx booster dose of RTS,S/AS01E and undergo a second controlled human malaria infection (CHMI) three to four weeks after vaccination. Additionally, subjects will be newly enrolled and will only undergo the sporozoite challenge as infectivity controls.
Interventions
- BIOLOGICAL RTS,S/AS01E (SB257049)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-02-05 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03824236
The ClinicalTrials.gov registry entry for NCT03824236 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RTS,S/AS01E (SB257049) is the first listed.
NCT03824236 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03824236 about?
NCT03824236 is a clinical study titled "A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults". MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study (follow-up to MALARIA...
What is the current status of trial NCT03824236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2019-02-05. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03824236?
The interventions under investigation include: RTS,S/AS01E (SB257049) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03824236?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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