- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263040
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-64 years old, inclusive, as of October 1st of year of enrolment;
- Healthcare worker, broadly defined as a person either providing health care, or working in an acute care hospital or long term healthcare facility;
- 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;
- Understand the study, agree to its requirements, and give written consent;
Exclusion Criteria:
- Receipt of influenza vaccine for the current northern hemisphere season prior to randomization;
- Serious adverse event to a previous dose of influenza vaccine;
- Immunoglobulin E mediated allergic reaction to a previous dose of influenza vaccine or to any excipients in the study vaccines
- Previous episode of Guillain-Barré syndrome with 6 weeks of receiving an influenza vaccine;
- Receipt of immunoglobulins, blood or blood-derived products in the past 3 months;
- 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
- Plans to receive any vaccine, initiate any medication, or be admitted to hospital before day 21 after vaccination (visit 2);
- 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)
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Influenza vaccine
|
Active Comparator: 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
|
Influenza vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Seroconversion to A/California/07/2009 (H1N1)
Time Frame: 21 days (18-28)
|
Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay.
4-fold or greater increase.
|
21 days (18-28)
|
Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)
Time Frame: 21 days post vaccination (18-28)
|
Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay
|
21 days post vaccination (18-28)
|
Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013
Time Frame: 21 days post-vaccination (18-28)
|
Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay
|
21 days post-vaccination (18-28)
|
Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)
Time Frame: 21 days post vaccination (18-28)
|
Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay
|
21 days post vaccination (18-28)
|
Number of Participants With Seroconversion to B/Massachusetts/02/2012
Time Frame: 21 days post-vaccination (18-28)
|
Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay
|
21 days post-vaccination (18-28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
Time Frame: 21 days (18-28)
|
GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay
|
21 days (18-28)
|
Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
Time Frame: 21 days (18-28)
|
GMFR (mean fold increase) time2/time1, as measured by HAI titres
|
21 days (18-28)
|
Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
Time Frame: 21 days (18-28)
|
GMFR (mean fold increase) time2/time1, as measured by HAI titres
|
21 days (18-28)
|
Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated
Time Frame: 21 days (18-28)
|
GMFR (mean fold increase) time2/time1, as measured by HAI titres
|
21 days (18-28)
|
Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated
Time Frame: 21 days (18-28)
|
GMFR (mean fold increase) time2/time1, as measured by HAI titres
|
21 days (18-28)
|
Number of Participants Reporting Adverse Event: Injection Site
Time Frame: 7 days
|
Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising
|
7 days
|
Number of Participants Reporting Adverse Event: Systemic
Time Frame: 7 days
|
Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness Defined as: None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities |
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0909
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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