Open-Label Influenza Vaccine Evaluation (OLIVE)

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)

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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