Clinical trial NCT02872311: Open-Label Influenza Vaccine Evaluation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: Vaccine
Influenza
High Dose
Adjuvanted
Recombinant
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-08-19
Enrollment: 179
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.
* Willing and able to give informed consent prior to study enrollment
* Able to comply with study requirements.

Exclusion Criteria:

* Prior receipt of 2016-17 influenza vaccine
* Current participation in another clinical trial
* Presence of a contraindication to influenza vaccine

Primary outcomes:
measure: HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
timeFrame: Year 1, Day 28 post vaccination
measure: HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
timeFrame: Year 1, Day 182 post vaccination
measure: HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
timeFrame: Year 1, Day 365 post vaccination
measure: HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
timeFrame: Year 2, Day 28 post vaccination
measure: HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
timeFrame: Year 2, Day 182 post vaccination
Secondary outcomes:
measure: HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
timeFrame: Year 1, Day 28 post vaccination
measure: HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination
timeFrame: Year 1, Day 182 post vaccination
measure: HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination
timeFrame: Year 1, Day 365 post vaccination
measure: MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
timeFrame: Year 1, Day 28 post vaccination
measure: MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
timeFrame: Year 1, Day 182 post vaccination
measure: MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
timeFrame: Year 1, Day 365 post vaccination
measure: MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination
timeFrame: Year 2, Day 28 post vaccination
measure: HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination
timeFrame: Year 2, Day 28 post vaccination
measure: HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination
timeFrame: Year 2, Day 182 post vaccination
measure: HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination
timeFrame: Year 2, Day 28 post vaccination
measure: HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination
timeFrame: Year 2, Day 182 post vaccination
measure: Number of Participants With Vaccine Failure, Year 1
timeFrame: Year 1, Post season
measure: Number of Participants With Vaccine Failure, Year 2
timeFrame: Year 2, Post season
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
Study officials:
References:
citation: McLean HQ, Levine MZ, King JP, Flannery B, Belongia EA. Serologic response to sequential vaccination with enhanced influenza vaccines: Open label randomized trial among adults aged 65-74 years. Vaccine. 2021 Dec 3;39(49):7146-7152. doi: 10.1016/j.vaccine.2021.10.072. Epub 2021 Nov 10.