A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

Completed · Phase 3 · Has a placebo group

Conditions studied: Avian Influenza

In brief

This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.

Key facts

Study ID

NCT02839330

Run by

Seqirus

People needed

3196

Starts

2016-07-11

Expected to finish

2017-10-04

Last updated by the study team

2024-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.

You may not qualify if…

• Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
• Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
• Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
• Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
• Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.
• Individuals with known or suspected impairment of the immune system.

Where it is running

• Optimal Research, LLC — Huntsville, Alabama, United States
• Radiant Research — Chandler, Arizona, United States
• Clinical Research Consortium Arizona — Tempe, Arizona, United States
• Optimal Research Site — San Diego, California, United States
• California Research Foundation — San Diego, California, United States
• Clinical Research Consulting, LLC — Milford, Connecticut, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Optimal Research, LLC — Melbourne, Florida, United States
• Great Lakes Clinical Trials LLC — Chicago, Illinois, United States
• Optimal Research — Peoria, Illinois, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Optimal Research, LLC — Rockville, Maryland, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• RCR/United Medical Associates, PC — Binghamton, New York, United States
• Rochester Clinical Research, Inc — Rochester, New York, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• Aventiv Research — Columbus, Ohio, United States
• Medical Research South — Charleston, South Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Biogenics Research Institute — San Antonio, Texas, United States
• J. Lewis Research Inc.-Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. / FirstMed East — Salt Lake City, Utah, United States
• J. Lewis Research, Inc/Foothill Family Clinic South — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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