Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Study Overview
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Brief Summary
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This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people

Official Title
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Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Conditions
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Elderly Immune System

Intervention / Treatment
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* Biological: Flu Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent provided by the participant Age 20-40 years old with no underlying chronic diseases or age ≥65 years old Willing to receive influenza vaccination Older cohort has received their influenza vaccine for the previous influenza season - Exclusion Criteria: Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily) Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination Participant has received a community available influenza vaccine for the approaching influenza season Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential) -

Ages Eligible for Study
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Minimum Age: 20 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flu Vaccine SD<br>Fluzone Standard Dose Influenza Vaccine | Biological: Flu Vaccine<br> <br> * Other names: Fluzone HD;|
| Active Comparator: Flu Vaccine HD<br>Fluzone High Dose Influenza Vaccine | Biological: Flu Vaccine<br> <br> * Other names: Fluzone HD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Influenza Cases | Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season. | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccine