Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Influenza
In brief
The purpose of this study was to determine the dose-related safety, immunogenicity, and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults.
Key facts
- Study ID
- NCT00328107
- Run by
- Protein Sciences Corporation
- People needed
- 459
- Starts
- 2004-11-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2010-01-12
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Medically stable adults, aged 18-49 years.
- Provided informed consent prior to any study procedures.
- Able to comply with all study procedures.
- Available for follow-up for the duration of the influenza season.
- Women of child-bearing potential had a negative urine pregnancy test at the time of randomization and were willing to use an adequate form of contraception during the course of the study.
You may not qualify if…
- Any history of immunodeficiency or treatment with immunosuppressive medications. (Use of inhaled steroids or of topical steroids was not considered immunosuppressive; receipt of systemic glucocorticosteroids was not allowed if daily intake was >10 mg of prednisone or equivalent).
- Presence of high-risk conditions or other characteristics considered to be indications for influenza vaccination, as defined by the Advisory Committee on Immunization Practices (ACIP).
- Acute febrile illness (defined as having a temperature ≥100degreesF) or upper respiratory tract illness within 72 hours of vaccination.
- Use of experimental vaccines or any influenza vaccine after May 31st 2004 for the 2005 Southern Hemisphere or 2004 to 2005 Northern hemisphere epidemic seasons.
- Use of any experimental medication within 30 days prior to study vaccination
- Women who were pregnant or breast-feeding.
- Subjects with a history of Guillain-Barré syndrome.
- Receipt of parenteral immunoglobulin within 30 days prior to study vaccination.
- Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of response.
Where it is running
- Rochester Medical Center — Rochester, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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