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Open-Label Influenza Vaccine Evaluation (OLIVE)

M

Marshfield Clinic Research Foundation

Status

Completed

Conditions

Immune Response

Treatments

Biological: Standard Dose Influenza vaccine
Biological: Adjuvanted Influenza vaccine
Biological: Recombinant Influenza vaccine
Biological: High Dose Influenza vaccine

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02872311
MCL10416

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

65 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

179 participants in 5 patient groups

High Dose Influenza Vaccine
Active Comparator group
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.
Treatment:
Biological: High Dose Influenza vaccine
Adjuvanted Influenza Vaccine
Active Comparator group
Description:
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Treatment:
Biological: Adjuvanted Influenza vaccine
Standard Dose Influenza Vaccine+HD
Active Comparator group
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.
Treatment:
Biological: High Dose Influenza vaccine
Biological: Standard Dose Influenza vaccine
Standard Dose Influenza Vaccine +Adj
Active Comparator group
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.
Treatment:
Biological: Adjuvanted Influenza vaccine
Biological: Standard Dose Influenza vaccine
Standard Dose Influenza Vaccine+Recomb
Active Comparator group
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.
Treatment:
Biological: Recombinant Influenza vaccine
Biological: Standard Dose Influenza vaccine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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