Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults
The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and
 Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety
 and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65
 years of age.

 Primary Objective:

 -  To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone
 Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014
 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years
 of age.

 Observational objectives:

 -  To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and
 Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of
 the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in
 adults ≥ 65 years of age.

 -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone
 Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group
 with the historical requirements of the Committee for Human Medicinal Products (CHMP)
 Note for Guidance (NfG) CPMP/BWP/214/96.

 -  To submit sera from selected subjects to the Center for Biologics Evaluation and
 Research (CBER) for further analysis by the World Health Organization (WHO), the Centers
 for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to
 support formulation recommendations for subsequent influenza vaccines.
Participants 18 to < 65 years of age on enrollment will be randomized to receive either
 Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at
 enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose
 vaccine.

 Solicited adverse event (AE) information will be collected for 7 days after each vaccination,
 unsolicited AE and Serious adverse event information will be collected from Visit 1 to Visit
 2. Total duration of participation in the study is approximately 21 days.
Inclusion Criteria:

 -  Subject is ≥ 18 years of age on the day of inclusion

 -  Informed consent form has been signed and dated

 -  Able to attend all scheduled visits and to comply with all trial procedures.

 Exclusion Criteria:

 -  History of serious adverse reaction to any influenza vaccine

 -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
 receive another vaccine before Visit 2.

 -  Participation in another interventional clinical trial investigating a vaccine, drug,
 medical device, or medical procedure in the 30 days preceding the first study
 vaccination or during the course of the study, unless no intervention for the other
 study occurred within the 30 days prior to the first study vaccination and none are
 planned before the subject would complete safety surveillance for the present study

 -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at
 the discretion of the Investigator

 -  Prior vaccination with any 2013-2014 formulation of influenza vaccine

 -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
 components, or a history of a life-threatening reaction to Fluzone Quadrivalent,
 Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of
 the same substances (the complete list of vaccine components is included in the
 Prescribing Information)

 -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months

 -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
 which may be a contraindication for intramuscular vaccination, at the discretion of
 the Investigator

 -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of
 non-childbearing potential, a female must be pre-menarche or post-menopausal for at
 least 1 year, surgically sterile, or using an effective method of contraception or
 abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after
 vaccination)

 -  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

 -  Personal history of Guillain-Barré syndrome

 -  Known or suspected congenital or acquired immunodeficiency; or receipt of
 immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
 within the preceding 6 months; or long-term systemic corticosteroid therapy
 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

 -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
 interfere with trial conduct or completion

 -  Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as
 reported by the subject

 -  Deprived of freedom by an administrative or court order, or in an emergency setting,
 or hospitalized involuntarily

 -  Current alcohol or drug addiction that, in the opinion of the Investigator, might
 interfere with the ability to comply with trial procedures

 -  Moderate or severe acute illness/infection (according to Investigator judgment) or
 febrile illness (temperature ≥ 100.4°F]) on the day of vaccination. A prospective
 subject should not be included in the study until the condition has resolved or the
 febrile event has subsided

 -  Identified as an Investigator or employee of the Investigator or study center with
 direct involvement in the proposed study, or identified as an immediate family member
 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
 direct involvement in the proposed study.