Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

Study Overview
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Brief Summary
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As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Official Title
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Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects

Conditions
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Orthomyxoviridae Infection, Influenza, Myxovirus Infection

Intervention / Treatment
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* Biological: Split, Inactivated, Trivalent Influenza Vaccine
* Biological: Split, Inactivated, Trivalent Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 65 years on the day of vaccination. Informed consent form signed. Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as long as their symptoms/signs are controlled). Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator's Brochure). Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months. Systemic corticosteroid therapy as follows: Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination Sporadic use with a dose of > 40 mg/day of oral prednisone for > 14 days in the 90 days preceding vaccination. Note: Use of topical or inhalant corticosteroids is acceptable. 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). Current abuse of alcohol 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. Vaccination against influenza in the past 6 months. Any vaccination in the 4 weeks preceding the trial vaccination. Vaccination planned in the 4 weeks following the trial vaccination. Participation in another clinical trial in the 4 weeks preceding trial vaccination. Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable. Chronic illness at a stage that could interfere with trial conduct or completion. Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity. Known thrombocytopenia or bleeding disorder contraindicating IM vaccination. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. Acute illness and febrile illness with a temperature ≥ 38.0°C [or 100.4°F]) 72 hours before or on the day of inclusion. Received antibiotics therapy within 72 hours preceding the trial vaccination. Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination. Any condition, which in the opinion of the investigator would pose a health risk to the participant.

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: Fluzone Intradermal (ID) Vaccine Group<br>Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine | Biological: Split, Inactivated, Trivalent Influenza Vaccine<br>* 0.1 mL, Intradermal<br>* Other names: Fluzone;|
| Active Comparator: Fluzone Intramuscular (IM) Vaccine Group<br>Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine. | Biological: Split, Inactivated, Trivalent Influenza Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Fluzone® 2006/2007 Formulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test. | Pre-vaccination and Day 28 post-vaccination | 
| Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40 | Day 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. | The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test. | Pre- and Day 28 post-vaccination | 
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine | Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. | Day 0 up to 7 days post-vaccination | 

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