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NCT00914732 · ClinicalTrials.gov registry record · Phase 2

Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally

A Phase 2 study of Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
523
Enrollment target
8
Study locations

NCT00914732 is a Phase 2 study of Smallpox that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 523 participants, below the 130,977-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00914732, a Phase 2 study of Smallpox, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
523 participants
Enrollment target
8
Study locations

Study Summary

Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.

Conditions Studied

Interventions

  • BIOLOGICAL MVA Smallpox Vaccine

Study Locations (8)

Washington

  • Group Health Research Institute - Seattle - Seattle
  • The University of Washington - Virology Research Clinic - Seattle

Georgia

  • Emory Vaccine Center - The Hope Clinic - Decatur

Iowa

  • University of Iowa - Vaccine Research & Education Unit - Iowa City

Maryland

  • University of Maryland School of Medicine - Center for Vaccine Development - Baltimore - Baltimore

Missouri

  • Saint Louis University - Center for Vaccine Development - St Louis

Tennessee

  • Vanderbilt University Hospital - Pediatric Clinical Research - Nashville

Texas

  • Baylor College of Medicine - Molecular Virology and Microbiology - Houston

Trial Details

FieldValue
Enrollment Target 523 participants
Start Date 2010-02
Est. Completion 2011-04
Phase Phase 2

What the Registry Record Tells You About NCT00914732

The ClinicalTrials.gov registry entry for NCT00914732 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 523 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130,977-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 1 intervention - of which MVA Smallpox Vaccine is the first listed.

NCT00914732 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Washington, Georgia, Iowa.

Frequently Asked Questions

What is clinical trial NCT00914732 about?

NCT00914732 is a clinical study titled "Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally". Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body...

What is the current status of trial NCT00914732?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 523 participants. The study started on 2010-02. Estimated completion is 2011-04.

What conditions does trial NCT00914732 study?

This clinical trial studies the following conditions: Smallpox.

What interventions are being tested in trial NCT00914732?

The interventions under investigation include: MVA Smallpox Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00914732?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00914732 being conducted?

This trial has 8 study locations across Georgia, Iowa, Maryland, Missouri, Tennessee. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.