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

Completed · Phase 2

Conditions studied: A/Vietnam/H5N1 Influenza Virus

In brief

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.

Key facts

Study ID

NCT02680002

Run by

Biomedical Advanced Research and Development Authority

People needed

422

Starts

2016-03-01

Expected to finish

2017-03-31

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or nonpregnant female
• Provide written informed consent prior to study-related procedures
• Stable health status
• Access to consistent and reliable means of telephone contact
• Able to understand and comply with planned study procedures
• Agree to stay in contact with site, and no plans to move from study area for study duration

You may not qualify if…

• Allergic to eggs, other vaccine components, or squalene-based adjuvants
• Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
• Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
• Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
• Have an active neoplastic disease or history of hematologic malignancy
• Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
• Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
• Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years

Where it is running

• Radiant Research, Inc. — Atlanta, Georgia, United States
• Clinical Research Advantage, Inc./Ridge Family Practice — Council Bluffs, Iowa, United States
• Johnson County Clin-Trials, Inc. — Lenexa, Kansas, United States
• Central Kentucky Researcch Associates, Inc. — Lexington, Kentucky, United States
• Radiant Research, Inc. — Edina, Minnesota, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States

Full record on ClinicalTrials.gov

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