Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Sanofi

Status and phase: Completed; Phase 2

Conditions: Orthomyxovirus Infection; Myxovirus Infection; Influenza

Treatments: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00775450

FID21

Details and patient eligibility

About

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Full description

Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.

Enrollment: 807 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Aged ≥ 65 years on the day of vaccination
• Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
• Informed consent form signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• Subject is medically stable.

Exclusion Criteria :

• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
• Receipt of any vaccination in the 4 weeks preceding the trial vaccination
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination
• Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
• Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).
• Personal or family history of Guillain-Barré Syndrome.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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807 participants in 5 patient groups

Group 1a: Fluzone ID After Fluzone ID

Experimental group

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 1b: Fluzone IM After Fluzone ID

Experimental group

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 2a: Fluzone IM After Fluzone IM

Active Comparator group

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 2b: Fluzone ID After Fluzone IM

Experimental group

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 3: Fluzone HD After Fluzone HD

Active Comparator group

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Biological: Influenza Virus Vaccine USP Trivalent Types A and B