Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Sanofi

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Study type

Interventional

Funder types

Industry

Identifiers

NCT01011049

UTN: U1111-1111-5095 (Other Identifier)

FID33

Details and patient eligibility

About

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Full description

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

Enrollment

1,250 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Aged 18 to 64 years on the day of vaccination in study FID33
Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) 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
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

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
For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test
Breast-feeding woman
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 (observational trials will be allowed)
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 surface (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 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, (those who have 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 will not be excluded).
Personal or family history of Guillain-Barré Syndrome

Temporary Exclusion Criteria:

A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:

Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Signs and symptoms of an acute infectious respiratory illness.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,250 participants in 4 patient groups

Group 1: Fluzone ID After Fluzone ID

Experimental group

Description:

Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 2: Fluzone IM After Fluzone ID

Experimental group

Description:

Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 3: Fluzone IM After Fluzone IM

Experimental group

Description:

Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Group 4: Fluzone ID After Fluzone IM

Experimental group

Description:

Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31

Treatment:

Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Trial contacts and locations

45

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