CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
A(H5N1) inactivated influenza vaccine (IIV) +1 morebiological
Likely dose
A(H5N1) inactivated influenza vaccine (IIV) 0.5 mlfrom 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.

Search/NCT02153671
NCT02153671Phase 2Completed
CompareCT.gov

Immunogenicity of OrniFlu® Inactivated Influenza Vaccine in Subjects Previously Immunized With Live Attenuated H5N2 Influenza Vaccine and in Non-vaccinated Subjects

PATH·interventional·Posted Jun 3, 2014·Updated Feb 18, 2019

In Brief

A Phase 2 clinical trial evaluating A(H5N1) inactivated influenza vaccine (IIV) and A(H5N2) live attenuated influenza vaccine (LAIV) for Influenza Vaccine. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Vaccine
CountriesRussia
CollaboratorsInstitute of Experimental Medicine, Russia, Research Institute of Influenza, Russia

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 3, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.1 years ago

Interventions

A(H5N1) inactivated influenza vaccine (IIV)biological

Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.

A(H5N2) live attenuated influenza vaccine (LAIV)biological

Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV