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NCT01857869 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01857869 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 64 participants.
The verdict
NCT01857869, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1 months and 1/5th standard dose at 7 months (delayed fractional dose group) and 257049 administered as three standard doses one month apart (0, 1, 2-month group) in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model. An additional, delayed sporozoite challenge will assess persistence of protection induced by the primary immune schedule and if an additional dose can provide protection in those unprotected by the initial vaccination series.
Interventions
- BIOLOGICAL GSK257049 Dosage 1
- BIOLOGICAL GSK257049 Dosage 2
- PROCEDURE Sporozoite-infected mosquitoes challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-05-20 |
| Est. Completion | 2014-12-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857869
The ClinicalTrials.gov registry entry for NCT01857869 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 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 3 interventions - of which GSK257049 Dosage 1 is the first listed.
NCT01857869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01857869 about?
NCT01857869 is a clinical study titled "Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults". This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1 months and 1/5th standard dose at 7 months (delayed fractional dose group) and 257049 administered as three standard ...
What is the current status of trial NCT01857869?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2013-05-20. Estimated completion is 2014-12-16.
What interventions are being tested in trial NCT01857869?
The interventions under investigation include: GSK257049 Dosage 1 (BIOLOGICAL), GSK257049 Dosage 2 (BIOLOGICAL), Sporozoite-infected mosquitoes challenge (PROCEDURE).
Who is sponsoring clinical trial NCT01857869?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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