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NCT01366534 · ClinicalTrials.gov registry record · Phase 2
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
A Phase 2 study of Malaria, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT01366534: Completed Phase 2 study of Malaria, sponsored by GlaxoSmithKline.
NCT01366534 is a Phase 2 study of Malaria that has completed, run by GlaxoSmithKline. The registered enrollment target is 67 participants, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366534, a Phase 2 study of Malaria, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.
Primary Outcome
P. falciparum parasitemia was defined as a positive blood slide.
Conditions Studied
Interventions
- BIOLOGICAL Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)
- BIOLOGICAL GSK Biologicals' malaria vaccine 257049 (2 doses)
- BIOLOGICAL GSK Biologicals' malaria vaccine 257049 (3 doses)
- OTHER Sporozoite challenge
Study Locations (1)
Maryland
- GSK Investigational Site - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-08-10 |
| Est. Completion | 2012-07-03 |
| Phase | Phase 2 |
What the finished NCT01366534 record still lists
NCT01366534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 4 interventions - of which Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) is the first listed.
NCT01366534 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01366534 about?
NCT01366534 is a clinical study titled "Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults". This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate th...
What is the current status of trial NCT01366534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2011-08-10. Estimated completion is 2012-07-03.
What conditions does trial NCT01366534 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT01366534?
The interventions under investigation include: Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) (BIOLOGICAL), GSK Biologicals' malaria vaccine 257049 (2 doses) (BIOLOGICAL), GSK Biologicals' malaria vaccine 257049 (3 doses) (BIOLOGICAL), Sporozoite challenge (OTHER).
Who is sponsoring clinical trial NCT01366534?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366534 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01366534's enrollment target sits among peer trials
67 15th of 27 higher than 13 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria 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.
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