Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM

Conditions
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Influenza, Orthomyxovirus Infection, Myxovirus Infection

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1a: Fluzone ID After Fluzone ID<br> | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.1 mL, Intradermal<br>* Other names: Fluzone;|
| Experimental: Group 1b: Fluzone IM After Fluzone ID<br> | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone;|
| Active Comparator: Group 2a: Fluzone IM After Fluzone IM<br> | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone;|
| Experimental: Group 2b: Fluzone ID After Fluzone IM<br> | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.1 mL, Intradermal<br>* Other names: Fluzone;|
| Active Comparator: Group 3: Fluzone HD After Fluzone HD<br> | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. | Days 0 through 7 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 28 post-vaccination | 
| Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. | Days 0 and 28 post-vaccination | 
| Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination. | Day 28 post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Orthomyxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly