CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 422 enrolled
Drug / intervention
7.5 mcg H5N1 (stored as monobulk) +5 morebiological
Likely dose
7.5 mcg H5N1 (stored as monobulk)from 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/NCT02680002
NCT02680002Phase 2Completed
CompareCT.gov

Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant

Biomedical Advanced Research and Development Authority·interventional·Posted Feb 11, 2016·Updated Aug 31, 2020

In Brief

A Phase 2 clinical trial evaluating 7.5 mcg H5N1 (stored as monobulk), 15 mcg H5N1 (stored as monobulk), and 4 other interventions for A/Vietnam/H5N1 Influenza Virus. Completed, enrolled 422 participants across 6 sites.

Detailed Summary

The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsA/Vietnam/H5N1 Influenza Virus
CountriesUnited States
CollaboratorsPPD Development, LP

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 11, 2016
Enrollment StartMar 1, 2016
Primary CompletionMay 13, 2016
Study CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.4 years ago

Interventions

7.5 mcg H5N1 (stored as monobulk)biological

15 mcg H5N1 (stored as monobulk)biological

90 mcg H5N1 (stored as monobulk)biological

90 mcg H5N1 (stored in vials)biological

MF59other

MF59 (stored as monobulk)other