Avian Influenza

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

NCT02839330 | PHASE 3 | INTERVENTIONAL

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.

26 Sites

3196 Participants

Recruiting

18 Years

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Find closest sites:

SUBMIT

Optimal Research, LLC

Huntsville,Alabama,United States,35802

Radiant Research

Chandler,Arizona,United States,85224

Clinical Research Consortium Arizona

Tempe,Arizona,United States,85283

Optimal Research Site

San Diego,California,United States,92108

California Research Foundation

San Diego,California,United States,92123

Clinical Research Consulting, LLC

Milford,Connecticut,United States,06460

Innovative Research of West Florida, Inc.

Clearwater,Florida,United States,33756

Optimal Research, LLC

Melbourne,Florida,United States,32934

Great Lakes Clinical Trials LLC

Chicago,Illinois,United States,60640

Optimal Research

Peoria,Illinois,United States,61614

Heartland Research Associates

Wichita,Kansas,United States,67207

Optimal Research, LLC

Rockville,Maryland,United States,20850

The Center for Pharmaceutical Research

Kansas City,Missouri,United States,64114

Sundance Clinical Research, LLC

Saint Louis,Missouri,United States,63141

RCRUnited Medical Associates, PC

Binghamton,New York,United States,13901

Rochester Clinical Research, Inc

Rochester,New York,United States,14609

PMG Research of Raleigh

Raleigh,North Carolina,United States,60640

PMG Research of WinstonSalem

Winston-Salem,North Carolina,United States,27609

Aventiv Research

Columbus,Ohio,United States,43213

Medical Research South

Charleston,South Carolina,United States,29407

Spartanburg Medical Research

Spartanburg,South Carolina,United States,29303

Biogenics Research Institute

San Antonio,Texas,United States,78229

J. Lewis Research Inc.Foothill Family Clinic

Salt Lake City,Utah,United States,84109

J. Lewis Research, Inc. FirstMed East

Salt Lake City,Utah,United States,84121

J. Lewis Research, IncFoothill Family Clinic South

Salt Lake City,Utah,United States,84121

J. Lewis Research, IncJordan River Family Medicine

South Jordan,Utah,United States,84095

Study Eligibility Criteria

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov