At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 930 enrolled

Drug / intervention

IVACFLU-A/H5N1 vaccine +1 morebiological

Likely dose

IVACFLU-A/H5N1 vaccine 0.6 mgfrom 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/NCT02612909

NCT02612909Phase 3Completed

Compare CT.gov

A Phase 2/3 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC

Institute of Vaccines and Medical Biologicals, Vietnam·interventional·Posted Nov 24, 2015·Updated May 21, 2019

In Brief

A Phase 3 clinical trial evaluating IVACFLU-A/H5N1 vaccine and Placebo for Avian Influenza. Completed, enrolled 930 participants across 2 sites.

Detailed Summary

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAvian Influenza

CountriesVietnam

CollaboratorsNational Institute of Hygiene and Epidemiology, Vietnam, World Health Organization, Department of Health and Human Services, PATH, FHI 360

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedNov 2015

Enrollment StartMar 2017

Primary CompletionAug 2017

Study CompletionAug 2017

TodayJul 2026

First PostedNov 24, 2015

Enrollment StartMar 7, 2017

Primary CompletionAug 29, 2017

Study CompletionAug 30, 2017

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 10.6 years ago

Interventions

IVACFLU-A/H5N1 vaccinebiological

Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative.

Placebobiological

Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate.