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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00743275

GRC41

Details and patient eligibility

About

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant is 18 years of age or older on the day of inclusion.
Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Participant in reasonably good health as assessed by the Investigator.
Participant willing and able to give informed consent.
For a woman, inability to bear a child or negative serum/urine pregnancy test.

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 in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Laboratory-confirmed influenza infection or 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 2.
Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.*
Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
Receipt of blood or blood products within the 3 months preceding enrollment in the study.
Diabetes mellitus requiring pharmacological control.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing potential, 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.
Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.