A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Sanofi

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Influenza virus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00835926

GRC16

Details and patient eligibility

About

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Full description

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Age of 18 years or greater.
Ambulatory.
In reasonably good health as assessed by the investigator.
Available for duration of the study (21 days + 2d).
Willing and able to meet protocol requirements.
Willing and able to give informed consent.

Exclusion Criteria :

Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Vaccination against influenza in the 6 months preceding enrollment in the study.
Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing.
Receipt of blood or blood products within the 3 months preceding enrollment in the study.
Diabetes
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.).
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.