Back to resultsOpen-Label Influenza Vaccine Evaluation (OLIVE)
Primary Purpose
Immune Response
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose Influenza vaccine
Adjuvanted Influenza vaccine
Standard Dose Influenza vaccine
Recombinant Influenza vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Immune Response focused on measuring Vaccine, Influenza, High Dose, Adjuvanted, Recombinant
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
Sites / Locations
- Marshfield Clinic - Marshfield Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
High Dose Influenza Vaccine
Adjuvanted Influenza Vaccine
Standard Dose Influenza Vaccine+HD
Standard Dose Influenza Vaccine +Adj
Standard Dose Influenza Vaccine+Recomb
Arm Description
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.
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
Number of Participants With Vaccine Failure, Year 1
Number of Participants with Vaccine Failure in Year 1 by vaccine type
Number of Participants With Vaccine Failure, Year 2
Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
Full Information
NCT ID
NCT02872311
First Posted
August 16, 2016
Last Updated
December 3, 2019
Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02872311
Brief Title
Open-Label Influenza Vaccine Evaluation
Acronym
OLIVE
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response
Keywords
Vaccine, Influenza, High Dose, Adjuvanted, Recombinant
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Influenza Vaccine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Adjuvanted Influenza Vaccine
Arm Type
Active Comparator
Arm Description
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Arm Title
Standard Dose Influenza Vaccine+HD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Dose Influenza Vaccine +Adj
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Dose Influenza Vaccine+Recomb
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
High Dose Influenza vaccine
Other Intervention Name(s)
Fluzone HD
Intervention Description
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Intervention Type
Biological
Intervention Name(s)
Adjuvanted Influenza vaccine
Other Intervention Name(s)
FluAd
Intervention Description
Licensed and FDA approved FluAd vaccine to be administered to study participants
Intervention Type
Biological
Intervention Name(s)
Standard Dose Influenza vaccine
Other Intervention Name(s)
Fluvirin Standard Dose
Intervention Description
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Intervention Type
Biological
Intervention Name(s)
Recombinant Influenza vaccine
Other Intervention Name(s)
FluBlok
Intervention Description
Licensed and FDA approved FluBlok vaccine to be administered to study participants
Primary Outcome Measure Information:
Title
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
Description
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17
Time Frame
Year 1, Day 28 post vaccination
Title
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
Description
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17
Time Frame
Year 1, Day 182 post vaccination
Title
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
Description
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17
Time Frame
Year 1, Day 365 post vaccination
Title
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
Description
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18
Time Frame
Year 2, Day 28 post vaccination
Title
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
Description
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18
Time Frame
Year 2, Day 182 post vaccination
Secondary Outcome Measure Information:
Title
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
Description
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17
Time Frame
Year 1, Day 28 post vaccination
Title
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination
Description
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17
Time Frame
Year 1, Day 182 post vaccination
Title
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination
Description
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17
Time Frame
Year 1, Day 365 post vaccination
Title
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
Description
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17
Time Frame
Year 1, Day 28 post vaccination
Title
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
Description
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17
Time Frame
Year 1, Day 182 post vaccination
Title
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
Description
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17
Time Frame
Year 1, Day 365 post vaccination
Title
MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination
Description
Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18
Time Frame
Year 2, Day 28 post vaccination
Title
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination
Description
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
Time Frame
Year 2, Day 28 post vaccination
Title
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination
Description
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
Time Frame
Year 2, Day 182 post vaccination
Title
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination
Description
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
Time Frame
Year 2, Day 28 post vaccination
Title
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination
Description
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
Time Frame
Year 2, Day 182 post vaccination
Title
Number of Participants With Vaccine Failure, Year 1
Description
Number of Participants with Vaccine Failure in Year 1 by vaccine type
Time Frame
Year 1, Post season
Title
Number of Participants With Vaccine Failure, Year 2
Description
Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
Time Frame
Year 2, Post season
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34774360
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.
Results Reference
derived
Learn more about this trial
Open-Label Influenza Vaccine Evaluation
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