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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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 group | Role | What they receive |
|---|---|---|
| High Dose Influenza Vaccine | Active comparator | This 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 Vaccine | Active comparator | This 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+HD | Active comparator | This 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 +Adj | Active comparator | This 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+Recomb | Active comparator | This 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.
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted19 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marshfield Clinic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Huong Nguyen, PhD, Marshfield Clinic Research Foundation
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02872311
- Acronym / sponsor ID
- OLIVE / MCL10416
- Conditions
- Immune Response
- Keywords
- Vaccine, Influenza, High Dose, Adjuvanted, Recombinant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Marshfield Clinic Research FoundationUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High Dose Influenza Vaccine | Active comparator | Biological: High Dose Influenza vaccineThis group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. |
| Adjuvanted Influenza Vaccine | Active comparator | Biological: Adjuvanted Influenza vaccineThis group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. |
| Standard Dose Influenza Vaccine+HD | Active comparator | Biological: High Dose Influenza vaccine, Biological: Standard Dose Influenza vaccineThis 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. |
| Standard Dose Influenza Vaccine +Adj | Active comparator | Biological: Adjuvanted Influenza vaccine, Biological: Standard Dose Influenza vaccineThis 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. |
| Standard Dose Influenza Vaccine+Recomb | Active comparator | Biological: Standard Dose Influenza vaccine, Biological: Recombinant Influenza vaccineThis 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. |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Prior receipt of 2016-17 influenza vaccine
- Current participation in another clinical trial
- Presence of a contraindication to influenza vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Influenza vaccineAlso: Fluzone HDLicensed and FDA approved Fluzone HD vaccine to be administered to study participants | Biological | High Dose Influenza Vaccine, Standard Dose Influenza Vaccine+HD |
| Adjuvanted Influenza vaccineAlso: FluAdLicensed and FDA approved FluAd vaccine to be administered to study participants | Biological | Adjuvanted Influenza Vaccine, Standard Dose Influenza Vaccine +Adj |
| Standard Dose Influenza vaccineAlso: Fluvirin Standard DoseLicensed and FDA approved Fluvirin vaccine to be administered to study participants | Biological | Standard Dose Influenza Vaccine +Adj, Standard Dose Influenza Vaccine+HD, Standard Dose Influenza Vaccine+Recomb |
| Recombinant Influenza vaccineAlso: FluBlokLicensed and FDA approved FluBlok vaccine to be administered to study participants | Biological | Standard Dose Influenza Vaccine+Recomb |
Primary outcome
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
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
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
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
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
13 secondary outcomes
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
Time frame: Year 1, Day 28 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination
Time frame: Year 1, Day 182 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination
Time frame: Year 1, Day 365 post vaccination
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
Time frame: Year 1, Day 28 post vaccination
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
Time frame: Year 1, Day 182 post vaccination
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
Time frame: Year 1, Day 365 post vaccination
MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination
Time frame: Year 2, Day 28 post vaccination
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
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
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
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
Number of Participants With Vaccine Failure, Year 1
Time frame: Year 1, Post season
Number of Participants With Vaccine Failure, Year 2
Time frame: Year 2, Post season
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34774360McLean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.