At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
H5N1 pISVbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 25, 2019·Updated Sep 22, 2025
In Brief
A Phase 1 clinical trial evaluating H5N1 pISV for Influenza. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartJan 2019
First PostedJan 2019
Primary CompletionApr 2019
Study CompletionMar 2020
TodayJul 2026
First PostedJan 25, 2019
Enrollment StartJan 8, 2019
Primary CompletionApr 18, 2019
Study CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.4 years ago
Interventions
H5N1 pISVbiological
Administered as an intramuscular (IM) injection