Influenza Clinical Trial
Official title:
Evaluation of the Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years.
Verified date | January 2010 |
Source | Protein Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 459 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Protein Sciences Corporation |
United States,
Treanor JJ, Schiff GM, Hayden FG, Brady RC, Hay CM, Meyer AL, Holden-Wiltse J, Liang H, Gilbert A, Cox M. Safety and immunogenicity of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1577-8 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years | influenza season | Yes | |
Secondary | Evaluation of the protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine at two different formulations in healthy adults aged 18-49 years | influenza season | No | |
Secondary | Evaluation of the immunogenicity of the H1 and B components when formulated at either 15µg or 45µg per component in healthy adults aged 18-49 years | 28 days | No |
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