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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 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.

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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.

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

FieldValue
Enrollment Target 67 participants
Start Date 2011-08-10
Est. Completion 2012-07-03
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01366534

The ClinicalTrials.gov registry entry for NCT01366534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (74% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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