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H7N9 Boost in Healthy Adults

NCT02586792 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-08-22

No results posted yet for this 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

Interventions

BIOLOGICAL

Monovalent influenza A/H7N9 virus vaccine

Monovalent influenza A/H7N9 virus vaccine.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2016-12-29
Completion
2016-12-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586792 on ClinicalTrials.gov