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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-12-31

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

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Detailed Description

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Conditions

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Elderly Immune System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Flu Vaccine SD

Fluzone Standard Dose Influenza Vaccine

Group Type ACTIVE_COMPARATOR

Flu Vaccine

Intervention Type BIOLOGICAL

Flu Vaccine HD

Fluzone High Dose Influenza Vaccine

Group Type ACTIVE_COMPARATOR

Flu Vaccine

Intervention Type BIOLOGICAL

Interventions

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Flu Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Fluzone HD

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent provided by the participant
2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
3. Willing to receive influenza vaccination
4. Older cohort has received their influenza vaccine for the previous influenza season

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Exclusion Criteria

1. Immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily)
2. 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
3. Participant has received a community available influenza vaccine for the approaching influenza season
4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

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Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Janet McElhaney

Senior Scientist, AMRIC, Professor (NOSM), Medical Lead for Senior's Care and Consulting Geriatrician (HSN), HSN Volunteer Association Chair in Geriatric Research

Responsibility Role PRINCIPAL_INVESTIGATOR