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Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals

NCT02151344 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-03-30

No results posted yet for this study

Summary

H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.

Conditions

  • Influenza A Virus, H7N9 Subtype

Interventions

BIOLOGICAL

H7N9 A/Anhui/13 ca influenza virus vaccine

Participants will receive approximately 10\^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.

BIOLOGICAL

Inactivated subvirion H7N9 vaccine

Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kawsar Talaat, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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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 NCT02151344 on ClinicalTrials.gov