Status:
UNKNOWN
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Lead Sponsor:
Health Sciences North Research Institute
Collaborating Sponsors:
UConn Health
Conditions:
Elderly Immune System
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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 determinant...
Eligibility Criteria
Inclusion
- 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
- 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)
- \-
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT02297542
Start Date
October 1 2014
End Date
December 1 2019
Last Update
August 1 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Center on Aging, UConn Health
Farmington, Connecticut, United States, 06030
2
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada, P3E 5J1