Trial | NCT02297542  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    fluarix ...

  • Study Participants

    85
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
Study Started
Oct 31
2014
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Aug 01
2018

Biological Flu Vaccine

  • Other names: Fluzone HD

Flu Vaccine SD Active Comparator

Fluzone Standard Dose Influenza Vaccine

Flu Vaccine HD Active Comparator

Fluzone High Dose Influenza Vaccine

Criteria 

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

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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)

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No Results Posted