A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV

NCT ID: NCT02263040

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-12-31

Brief Summary

The objective of this pilot study is to assess the immunogenicity and reactogenicity of Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare workers.

Detailed Description

This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in 100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the World Health Organization for the season of recruitment. All adverse events will be collected for 7 days following the injection, serious adverse events will be collected through day 21, and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will be seroconversion to each strain of vaccine included in the vaccine, as measured by change in hemagglutination inhibition assay (HAI) titer between day 0 to day 21.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High Dose Fluzone

Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg hemagglutinin per virus strain

Group Type: EXPERIMENTAL

Fluzone High-Dose

Intervention Type: BIOLOGICAL

Influenza vaccine

Fluzone (standard dose)

Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg hemagglutinin per virus strain for adults

Group Type: ACTIVE_COMPARATOR

Fluzone (standard dose)

Intervention Type: BIOLOGICAL

Influenza vaccine

Interventions

Fluzone High-Dose

Influenza vaccine

Intervention Type: BIOLOGICAL

Fluzone (standard dose)

Influenza vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 18-64 years old, inclusive, as of October 1st of year of enrolment;

2. Healthcare worker, broadly defined as a person either providing health care, or working in an acute care hospital or long term healthcare facility;

3. Has access to email and the internet for adverse event reporting, or is willing to complete forms on paper and deliver to the site study office;

4. Understand the study, agree to its requirements, and give written consent;

Exclusion Criteria

1. Receipt of influenza vaccine for the current northern hemisphere season prior to randomization;

2. Serious adverse event to a previous dose of influenza vaccine;

3. Immunoglobulin E mediated allergic reaction to a previous dose of influenza vaccine or to any excipients in the study vaccines

4. Previous episode of Guillain-Barré syndrome with 6 weeks of receiving an influenza vaccine;

5. Receipt of immunoglobulins, blood or blood-derived products in the past 3 months;

6. Receipt of another vaccine, or initiation of new medication, or hospital admission for any reason within the 30 days prior to the study dose of vaccine

7. Plans to receive any vaccine, initiate any medication, or be admitted to hospital before day 21 after vaccination (visit 2);

8. Known or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

9. Any condition, including but not limited to drug and alcohol addiction, which, in the opinion of the investigator might interfere with the ability to comply with trial conduct or completion;

10. Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day the vaccine dose is due (participant may receive dose of vaccine 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison J McGeer, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-0909

Identifier Type: -

Identifier Source: org_study_id