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Safety and Immunogenicity of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant

NCT02957656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-10-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).

Conditions

  • Influenza A Virus, H7N9 Subtype

Interventions

BIOLOGICAL

H7N9 pLAIV

10\^7.0 fluorescent focus units (FFU); delivered by an Accuspray device

BIOLOGICAL

H7N9 pIIV

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

AS03 adjuvant

Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Angela Branche · University of Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-06-30

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 NCT02957656 on ClinicalTrials.gov