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Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults

NCT01995695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-07-27

No results posted yet for this study

Summary

H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.

Conditions

  • Influenza A Virus, H7N9 Subtype

Interventions

BIOLOGICAL

Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine

Participants will receive approximately 10\^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine).

BIOLOGICAL

Inactivated subvirion H7N9 influenza vaccine

Participants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • John Treanor, M.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-01-31

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 NCT01995695 on ClinicalTrials.gov