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

Condition(s) targeted: Influenza

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

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

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.

Official title: Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.

Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation

Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)

Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Norfolk, Virginia 23507, United States

Starting date: August 2008
Last updated: January 17, 2014