Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone(R) in Healthy Adults

National Institute of Allergy and Infectious Diseases (NIAID)10 sites in 1 country1,597 target enrollmentSeptember 2005

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 1597
Locations: 10
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.

Detailed Description

This is a multi-center, randomized, partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination. After the completion of the trial, all subjects will be offered influenza vaccine of the 2005-2006 formulation.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

February 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Inclusion Criteria

•Subject is healthy, as determined by medical history
•Over 18 years of age and not yet 65 years old
•Provides written informed consent
•Able to attend all scheduled visits and to comply with all trial procedures
•Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing potential must agree to be abstinent or to use a licensed form of barrier or hormonal contraception for the entire study period, and have a negative pregnancy test within 24 hours prior to vaccination.

Exclusion Criteria

•Breast-feeding
•Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
•Planned participation in another clinical trial during the present trial period
•History of Guillain-Barré Syndrome
•Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
•Hypersensitivity to any of the vaccine components (including eggs or egg products or thimerosol and gelatin) or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
•Chronic illness that could interfere with trial conduct or completion
•Blood or blood-derived products received in the past 3 months
•Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study
•Vaccination planned within the 4 weeks following the trial vaccination