Status:
COMPLETED
Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
Lead Sponsor:
Protein Sciences Corporation
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00328107
Start Date
November 1 2004
End Date
August 1 2005
Last Update
January 12 2010
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Rochester Medical Center
Rochester, New York, United States, 14642
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
University of Virginia Health System
Charlottesville, Virginia, United States, 22908