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NCT00294099 · ClinicalTrials.gov registry record · Phase 1

H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults

A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
600
Enrollment target
7
Study locations

NCT00294099 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT00294099, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
600 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
  • BIOLOGICAL Aluminum hydroxide

Study Locations (7)

Iowa

  • University of Iowa - Iowa City

Maryland

  • University of Maryland Baltimore - Baltimore

Missouri

  • Saint Louis University - St Louis

New York

  • University of Rochester - Rochester

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Tennessee

  • Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2006-03
Est. Completion 2007-03
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00294099

The ClinicalTrials.gov registry entry for NCT00294099 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% 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 Influenza appearing as the primary indexed condition, and to 2 interventions - of which Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) is the first listed.

NCT00294099 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Iowa, Maryland, Missouri.

Frequently Asked Questions

What is clinical trial NCT00294099 about?

NCT00294099 is a clinical study titled "H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults". The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximat...

What is the current status of trial NCT00294099?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2006-03. Estimated completion is 2007-03.

What conditions does trial NCT00294099 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00294099?

The interventions under investigation include: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL).

Who is sponsoring clinical trial NCT00294099?

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 NCT00294099 being conducted?

This trial has 7 study locations across Iowa, Maryland, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.