CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 75 enrolled
Drug / intervention
IVACFLU-A/H5N1, 7.5 mcg +2 morebiological
Likely dose
IVACFLU-A/H5N1, 7.5 mcgfrom 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/NCT02171819
NCT02171819Phase 1Completed
CompareCT.gov

A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam

Institute of Vaccines and Medical Biologicals, Vietnam·interventional·Posted Jun 24, 2014·Updated Mar 14, 2019

In Brief

A Phase 1 clinical trial evaluating IVACFLU-A/H5N1, 7.5 mcg, IVACFLU-A/H5N1, 15 mcg, and 1 other intervention for Influenza A Subtype H5N1 Infection. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A Subtype H5N1 Infection
CountriesVietnam
CollaboratorsDepartment of Health and Human Services, World Health Organization, Institut Pasteur, PATH

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 24, 2014
Enrollment StartJun 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.0 years ago

Interventions

IVACFLU-A/H5N1, 7.5 mcgbiological

Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.

IVACFLU-A/H5N1, 15 mcgbiological

Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose

Placebo Comparatorother

PBS, pH 7.2 in 0.5 mL single-dose vials.