NCT02872311

Open-Label Influenza Vaccine Evaluation

Open-Label, Randomized Study of Immune Response to Licensed Influenza Vaccines in Adults 65-74 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2016-17 and 2017-18)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Marshfield Clinic Research Foundation · Academic / Other
• Sex: All
• Age: 65 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.

Conditions

• Immune Response

Interventions

Type	Name	Description
BIOLOGICAL	High Dose Influenza vaccine	Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
BIOLOGICAL	Adjuvanted Influenza vaccine	Licensed and FDA approved FluAd vaccine to be administered to study participants
BIOLOGICAL	Standard Dose Influenza vaccine	Licensed and FDA approved Fluvirin vaccine to be administered to study participants
BIOLOGICAL	Recombinant Influenza vaccine	Licensed and FDA approved FluBlok vaccine to be administered to study participants

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-04-01
• Completion: 2018-09-01
• First posted: 2016-08-19
• Last updated: 2025-12-10
• Results posted: 2019-12-19

Locations

1 site across 1 country: United States