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NCT02586792 · ClinicalTrials.gov registry record · Phase 2

H7N9 Boost in Healthy Adults

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

Completed
Registry status
Phase 2
Development phase
27
Enrollment target
1
Study location

NCT02586792 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 36,804-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

NCT02586792, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

The study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28 days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1) assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.

Conditions Studied

Interventions

  • BIOLOGICAL Monovalent influenza A/H7N9 virus vaccine

Study Locations (1)

Texas

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

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2016-01-12
Est. Completion 2016-12-29
Phase Phase 2

What the Registry Record Tells You About NCT02586792

The ClinicalTrials.gov registry entry for NCT02586792 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,804-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 1 intervention - of which Monovalent influenza A/H7N9 virus vaccine is the first listed.

NCT02586792 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02586792 about?

NCT02586792 is a clinical study titled "H7N9 Boost in Healthy Adults". The study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults ...

What is the current status of trial NCT02586792?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2016-01-12. Estimated completion is 2016-12-29.

What conditions does trial NCT02586792 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT02586792?

The interventions under investigation include: Monovalent influenza A/H7N9 virus vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02586792?

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 NCT02586792 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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