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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

Conditions
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Influenza

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 1: Fluzone ID After Fluzone ID<br>Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31 | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.1 mL, Intradermal<br>|
| Experimental: Group 2: Fluzone IM After Fluzone ID<br>Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31 | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone® 2009/2010 Northern Hemisphere Formulation;|
| Experimental: Group 3: Fluzone IM After Fluzone IM<br>Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31 | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone® 2009/2010 Northern Hemisphere Formulation;|
| Experimental: Group 4: Fluzone ID After Fluzone IM<br>Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31 | Biological: Influenza Virus Vaccine USP Trivalent Types A and B<br>* 0.1 mL, Intradermal<br>|

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 Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature). | Day 0 through Day 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 Vaccine | Serum antibody titers for 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 Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination. | Day 28 post-vaccination | 
| Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular 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, Fluzone Vaccine, Intradermal Injections, Adults