Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

Study Overview
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Brief Summary
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This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment. Objectives: For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 For all groups, to describe the safety

Detailed Description
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All participants will receive a single dose of study vaccine on Day 0. Immunogenicity data will be collected before vaccination and on Day 21 post vaccination. Safety will be assessed throughout the study.

Official Title
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Immunogenicity and Safety of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

Conditions
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Influenza

Intervention / Treatment
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* Biological: IDflu™: Split virion inactivated influenza vaccine
* Biological: Vaxigrip®: Split virion inactivated influenza vaccine
* Biological: IDflu™: Split virion inactivated influenza vaccine
* Biological: Vaxigrip®: Split virion inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years and over on the day of inclusion Informed consent form has been signed and dated 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 systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances Known pregnancy, or a positive urine pregnancy test Currently breastfeeding a child History of seasonal influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine) Receipt of an influenza vaccine (either seasonal or pandemic vaccine) in a clinical trial within the previous 12 months Known or suspected congenital or acquired immunodeficiency, resulting for example from: end-stage renal disease requiring dialysis; active neoplastic disease or active hematologic malignancy; receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion History of thrombocytopenia, contraindicating intramuscular (IM) vaccination Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination, under the investigator's judgment Receipt of any vaccine in the 4 weeks preceding the trial vaccination Planned receipt of any vaccine in the 3 weeks following the trial vaccination 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 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 department, with direct involvement in the proposed study or other studies under the direction of that Investigator or study department as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

Ages Eligible for Study
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Minimum Age: 18 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: Adult Intradermal (ID) Vaccine<br>Participants aged 18 to 59 years will be vaccinated with IDflu™ influenza vaccine | Biological: IDflu™: Split virion inactivated influenza vaccine<br>* Single dose 0.1 mL, intradermal<br>* Other names: IDflu™;|
| Active Comparator: Group 2: Adult Intramuscular (IM) Vaccine<br>Participants aged 18 to 59 years will be vaccinated with Vaxigrip® Influenza vaccine | Biological: Vaxigrip®: Split virion inactivated influenza vaccine<br>* Single dose 0.5 mL, intramuscular<br>* Other names: Vaxigrip®;|
| Experimental: Group 3: Elderly Intradermal (ID) Vaccine<br>Participants aged 60 years or older will be vaccinated with IDflu™ Influenza vaccine | Biological: IDflu™: Split virion inactivated influenza vaccine<br>* Single dose 0.1 mL, intradermal<br>* Other names: IDflu™;|
| Active Comparator: Group 4: Elderly Intramuscular (IM) Vaccine<br>Participants aged 60 years or older will be vaccinated with Vaxigrip® Influenza vaccine | Biological: Vaxigrip®: Split virion inactivated influenza vaccine<br>* Single dose 0.5 mL, intramuscular<br>* Other names: Vaxigrip®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique. |  | 21 days post-vaccination | 
| Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination |  | Day 0 to up to 21 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Influenza Virus Vaccines, Intradermal Injections