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Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
NCT01366534 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01366534
The ClinicalTrials.gov registry entry for NCT01366534 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01366534 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01366534?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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