Clinical trial NCT02263040: A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV
Official title: A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: influenza vaccine
adult
immunogenicity
reactogenicity
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Seroconversion to A/California/07/2009 (H1N1)
timeFrame: 21 days (18-28)
measure: Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)
timeFrame: 21 days post vaccination (18-28)
measure: Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013
timeFrame: 21 days post-vaccination (18-28)
measure: Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)
timeFrame: 21 days post vaccination (18-28)
measure: Number of Participants With Seroconversion to B/Massachusetts/02/2012
timeFrame: 21 days post-vaccination (18-28)
Secondary outcomes:
measure: Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
timeFrame: 21 days (18-28)
measure: Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
timeFrame: 21 days (18-28)
measure: Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
timeFrame: 21 days (18-28)
measure: Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated
timeFrame: 21 days (18-28)
measure: Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated
timeFrame: 21 days (18-28)
measure: Number of Participants Reporting Adverse Event: Injection Site
timeFrame: 7 days
measure: Number of Participants Reporting Adverse Event: Systemic
timeFrame: 7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Allison J McGeer, MD
role: PRINCIPAL_INVESTIGATOR
References: