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Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

Influenza Clinical Trial

Official title:
An Exploration of a Prime-Boost Approach for Universal Influenza Vaccination: Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines.

Clinical Trial Description

This study will evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines (pLAIVs). Participants will be enrolled in two cohorts. Cohort 1 will include participants who received two doses of live attenuated H2N2, H6N1, or H9N2 influenza vaccine during a prior Center for Immunization Research (CIR) study; Cohort 2 will include participants who have never previously received a pLAIV. Participants in both cohorts will receive one dose of H5N1 pISV vaccine by injection at Day 0. Participants will attend study visits on Days 0, 7, 14, 28, 56, 90, and 360. Study visits may include a physical examination, medical history, and blood and urine collection. All participants will be followed for approximately 360 days after receiving the H5N1 pISV vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03816878
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date January 8, 2019
Completion date March 17, 2020
View Details
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