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NCT00133471 · ClinicalTrials.gov registry record · Phase 1

Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

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

Completed
Registry status
Phase 1
Development phase
96
Enrollment target
1
Study location

NCT00133471 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 96 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00133471, 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
96 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.

Conditions Studied

Interventions

  • BIOLOGICAL Influenza A/H9N2 vaccine
  • DRUG MF59 adjuvant

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2005-03
Est. Completion 2005-12
Phase Phase 1

What the Registry Record Tells You About NCT00133471

The ClinicalTrials.gov registry entry for NCT00133471 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza 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 Influenza appearing as the primary indexed condition, and to 2 interventions - of which Influenza A/H9N2 vaccine is the first listed.

NCT00133471 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00133471 about?

NCT00133471 is a clinical study titled "Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults". The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the ex...

What is the current status of trial NCT00133471?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2005-03. Estimated completion is 2005-12.

What conditions does trial NCT00133471 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00133471?

The interventions under investigation include: Influenza A/H9N2 vaccine (BIOLOGICAL), MF59 adjuvant (DRUG).

Who is sponsoring clinical trial NCT00133471?

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 NCT00133471 being conducted?

This trial has 1 study location across Texas. 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

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