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Immune ResponseOLIVENCT02872311

Open-Label Influenza Vaccine Evaluation

A study testing High Dose Influenza vaccine, Adjuvanted Influenza vaccine and Standard Dose Influenza vaccine in people with Immune Response, run by Marshfield Clinic Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 74 years
Conditions the study is for
Immune Response
What is being tested?
High Dose Influenza vaccine, Adjuvanted Influenza vaccine and Standard Dose Influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 siteUnited States
Study dates
Sep 2016to Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 74 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

Other trials in United States

About this study

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)

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
Being tested
High Dose Influenza vaccine, Adjuvanted Influenza vaccine, Standard Dose Influenza vaccine, Recombinant Influenza vaccine
Keywords
Vaccine, Influenza, High Dose, Adjuvanted, Recombinant
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose Influenza vaccineBiological

    Also called Fluzone HD

    Licensed and FDA approved Fluzone HD vaccine to be administered to study participants

  • Adjuvanted Influenza vaccineBiological

    Also called FluAd

    Licensed and FDA approved FluAd vaccine to be administered to study participants

  • Standard Dose Influenza vaccineBiological

    Also called Fluvirin Standard Dose

    Licensed and FDA approved Fluvirin vaccine to be administered to study participants

  • Recombinant Influenza vaccineBiological

    Also called FluBlok

    Licensed and FDA approved FluBlok vaccine to be administered to study participants

Study groups in NCT02872311
Study groupRoleWhat they receive
High Dose Influenza VaccineActive comparatorThis group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Receives: Biological: High Dose Influenza vaccine
Adjuvanted Influenza VaccineActive comparatorThis group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Receives: Biological: Adjuvanted Influenza vaccine
Standard Dose Influenza Vaccine+HDActive comparatorThis group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.
Receives: Biological: High Dose Influenza vaccine; Biological: Standard Dose Influenza vaccine
Standard Dose Influenza Vaccine +AdjActive comparatorThis group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Receives: Biological: Adjuvanted Influenza vaccine; Biological: Standard Dose Influenza vaccine
Standard Dose Influenza Vaccine+RecombActive comparatorThis group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Receives: Biological: Standard Dose Influenza vaccine; Biological: Recombinant Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17

    Measured: Year 1, Day 28 post vaccination

  2. HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17

    Measured: Year 1, Day 182 post vaccination

  3. HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17

    Measured: Year 1, Day 365 post vaccination

  4. HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18

    Measured: Year 2, Day 28 post vaccination

  5. HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18

    Measured: Year 2, Day 182 post vaccination

Secondary outcomes (13)
  1. HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination

    Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17

    Measured: Year 1, Day 28 post vaccination

  2. HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination

    Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17

    Measured: Year 1, Day 182 post vaccination

  3. HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination

    Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17

    Measured: Year 1, Day 365 post vaccination

  4. MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination

    Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17

    Measured: Year 1, Day 28 post vaccination

  5. MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination

    Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17

    Measured: Year 1, Day 182 post vaccination

  6. MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination

    Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17

    Measured: Year 1, Day 365 post vaccination

  7. MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination

    Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18

    Measured: Year 2, Day 28 post vaccination

  8. HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18

    Measured: Year 2, Day 28 post vaccination

  9. HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination

    Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18

    Measured: Year 2, Day 182 post vaccination

  10. HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination

    Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18

    Measured: Year 2, Day 28 post vaccination

  11. HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination

    Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18

    Measured: Year 2, Day 182 post vaccination

  12. Number of Participants With Vaccine Failure, Year 1

    Number of Participants with Vaccine Failure in Year 1 by vaccine type

    Measured: Year 1, Post season

  13. Number of Participants With Vaccine Failure, Year 2

    Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history

    Measured: Year 2, Post season

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionApr 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02872311
Sponsor's protocol ID
MCL10416
Acronym
OLIVE
Status last verified
Nov 2025
First submitted
16 Aug 2016
Last updated
10 Dec 2025
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34774360

Questions about this trial

What is this clinical trial studying?

A study testing High Dose Influenza vaccine, Adjuvanted Influenza vaccine and Standard Dose Influenza vaccine in people with Immune Response, run by Marshfield Clinic Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination (time frame: Year 1, Day 28 post vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02872311, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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