Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004

Resilience Government Services, Inc.1 site in 1 countryDecember 2003

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Resilience Government Services, Inc.
Locations: 1
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

July 2004

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Eligibility Criteria

Inclusion Criteria

•Male and female subjects will be eligible for participation in this study if they:
•are \>= 18 and \<= 60 years old (for Stratum A only);
•are \> 60 years old (for Stratum B only);
•are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
•will reliably keep a daily record of symptoms;
•understand the nature of the study, agree to its provisions, and give written informed consent;
•if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria

•Male and female subjects will be excluded from participation in this study if they:
•have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
•suffer from any kind of immunodeficiency;
•suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
•have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
•have received a blood transfusion or immunoglobulins within one month of study entry;
•have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
•have a rash or dermatological condition which may interfere with injection site reaction rating;
•have a known or suspected problem with drug or alcohol abuse;
•are unable to lead an independent life either physically or mentally;