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OpenTrials
Completed

NCT Number: NCT02872311

Open-Label Influenza Vaccine Evaluation

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.

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Key information

Conditions

Immune Response Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose Influenza vaccine

Biological

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

Other names: Fluzone HD

Adjuvanted Influenza Vaccine

Biological

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

Other names: FluAd

Standard Dose Influenza vaccine

Biological

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

Other names: Fluvirin Standard Dose

Recombinant Influenza vaccine

Biological

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

Other names: FluBlok

Primary outcomes

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

    Time frame: Year 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

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

    Time frame: Year 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

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

    Time frame: Year 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

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

    Time frame: Year 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

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

    Time frame: Year 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

Secondary outcomes

  1. HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination

    Time frame: Year 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

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

    Time frame: Year 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

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

    Time frame: Year 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  12. Number of Participants With Vaccine Failure, Year 1

    Time frame: Year 1, Post season

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

  13. Number of Participants With Vaccine Failure, Year 2

    Time frame: Year 2, Post season

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

Sponsors and collaborators

Lead sponsor

Marshfield Clinic Research Foundation

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study 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)

Acronym: OLIVE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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