This trial is active, not recruiting.

Condition elderly immune system
Treatment flu vaccine
Phase phase 4
Sponsor Health Sciences North Research Institute
Collaborator University of Connecticut Health Center
Start date October 2014
End date March 2018
Trial size 85 participants
Trial identifier NCT02297542, NIH R01


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model factorial assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
Fluzone Standard Dose Influenza Vaccine
flu vaccine Fluzone HD
(Active Comparator)
Fluzone High Dose Influenza Vaccine
flu vaccine Fluzone HD

Primary Outcomes

Number of Influenza Cases
time frame: five years

Eligibility Criteria

Male or female participants at least 20 years old.

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 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)

Additional Information

Official title Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Principal investigator Janet E McElhaney, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Health Sciences North Research Institute.