Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine

Resilience Government Services, Inc.3 sites in 2 countries423 target enrollmentJanuary 2006

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Resilience Government Services, Inc.
Enrollment: 423
Locations: 3
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

TBD

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 who
•are 18 to 45 years of age, inclusive, on the day of screening;
•have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
•are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
•agree to keep a daily record of symptoms;
•if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria

•Subjects who
•have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
•have received any vaccination within 2 weeks prior to vaccination in this study;
•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) that can be expected to influence immune response;
•have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
•have received a blood transfusion or immunoglobulins within 30 days of study entry;
•have donated blood or plasma within 30 days of study entry;
•have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
•have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;