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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01857869 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The definition of malaria for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.
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 |
What the finished NCT01857869 record still lists
NCT01857869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which GSK257049 Dosage 1 is the first listed.
NCT01857869 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01857869's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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