Open-Label Influenza Vaccine Evaluation

NCT02872311 | Completed Results

• 1 other identifier: MCL10416
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response

Keywords

Vaccine; Influenza; High Dose; Adjuvanted; Recombinant

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  Year 2, Day 182 post vaccination

Secondary Outcomes (13)

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

  Year 1, Day 28 post vaccination

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

  Year 1, Day 182 post vaccination

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

  Year 1, Day 365 post vaccination

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

  Year 1, Day 28 post vaccination

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

  Year 1, Day 182 post vaccination

Study Arms (5)

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.

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.

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.

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.

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.

Biological: Standard Dose Influenza vaccine; Biological: Recombinant Influenza vaccine

Interventions

High Dose Influenza vaccine BIOLOGICAL

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

Also known as: Fluzone HD

High Dose Influenza Vaccine; Standard Dose Influenza Vaccine+HD

Adjuvanted Influenza vaccine BIOLOGICAL

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

Also known as: FluAd

Adjuvanted Influenza Vaccine; Standard Dose Influenza Vaccine +Adj

Standard Dose Influenza vaccine BIOLOGICAL

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

Also known as: Fluvirin Standard Dose

Standard Dose Influenza Vaccine +Adj; Standard Dose Influenza Vaccine+HD; Standard Dose Influenza Vaccine+Recomb

Recombinant Influenza vaccine BIOLOGICAL

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

Also known as: FluBlok

Standard Dose Influenza Vaccine+Recomb

Eligibility Criteria

• Age: 65 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

• 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.

  PMID: 34774360 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; FluBlok

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Project Manager
• Organization: Marshfield Clinic Research Institute

king.jennifer@marshfieldresearch.org

715-389-5088

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 10, 2025
• Results First Posted: December 19, 2019

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)