Open-Label Influenza Vaccine Evaluation

Not Applicable

Completed

• Conditions: Immune Response
• Interventions: Biological: Standard Dose Influenza vaccine; Biological: High Dose Influenza vaccine; Biological: Adjuvanted Influenza vaccine; Biological: Recombinant Influenza vaccine

• Registration Number: NCT02872311
• Lead Sponsor: Marshfield Clinic Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2016-09
• Primary Completion: 2018-04
• Study Completion: 2018-09
• Results First Submitted: 2019-04-23
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Results First Posted: 2019-12-19
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dose Influenza Vaccine+Recomb	Standard Dose Influenza vaccine	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.
High Dose Influenza Vaccine	High Dose Influenza vaccine	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.
Standard Dose Influenza Vaccine +Adj	Standard Dose Influenza vaccine	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.
Adjuvanted Influenza Vaccine	Adjuvanted Influenza vaccine	This 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	High Dose Influenza vaccine	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.
Standard Dose Influenza Vaccine+HD	Standard Dose Influenza vaccine	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.
Standard Dose Influenza Vaccine +Adj	Adjuvanted Influenza vaccine	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.
Standard Dose Influenza Vaccine+Recomb	Recombinant Influenza vaccine	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.

Primary Outcome Measures

Name	Time	Method
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination	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 1 Day 28 Post Vaccination	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	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	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 182 Post Vaccination	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 Outcome Measures

Name	Time	Method
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination	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
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination	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
Number of Participants With Vaccine Failure, Year 2	Year 2, Post season	Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination	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
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination	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 (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination	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	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 Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination	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
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination	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
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination	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	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	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	Year 1, Post season	Number of Participants with Vaccine Failure in Year 1 by vaccine type

Trial Locations

Locations (1)

Marshfield Clinic - Marshfield Center; 🇺🇸 Marshfield, Wisconsin, United States