A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

Sanofi

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: High-Dose Trivalent Inactivated Influenza Vaccine

Biological: Trivalent Inactivated Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01258595

UTN: U1111-1113-3648 (Other Identifier)

FIM09

Details and patient eligibility

About

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Full description

Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.

Enrollment

300 patients

Sex

All

Ages

50 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 50 to 64 years (inclusive) on the day of vaccination
Informed consent form has been signed and dated
Medically stable
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

Exclusion criteria

Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)
Receipt of seasonal or pandemic influenza vaccine in the past 6 months
Receipt of blood or blood-derived products in the past 3 months
Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances
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
Neoplastic disease or any hematologic malignancy
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
Personal history of Guillain-Barré Syndrome
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator