NCT02680002

Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Biomedical Advanced Research and Development Authority · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored \>10 years) and adjuvant (ie, stored \>5 years).

Conditions

• A/Vietnam/H5N1 Influenza Virus

Interventions

Type	Name	Description
BIOLOGICAL	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)
OTHER	MF59
OTHER	MF59 (stored as monobulk)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-13
• Completion: 2017-03-31
• First posted: 2016-02-11
• Last updated: 2020-08-31
• Results posted: 2020-08-31

Locations

6 sites across 1 country: United States