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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
170
Influenza vaccine
Influenza vaccine
Mount Sinai Hospital
Toronto, Ontario, Canada
Number of Participants With Seroconversion to A/California/07/2009 (H1N1)
Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.
Time frame: 21 days (18-28)
Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)
Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay
Time frame: 21 days post vaccination (18-28)
Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013
Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay
Time frame: 21 days post-vaccination (18-28)
Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)
Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay
Time frame: 21 days post vaccination (18-28)
Number of Participants With Seroconversion to B/Massachusetts/02/2012
Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay
Time frame: 21 days post-vaccination (18-28)
Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
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GMFR (mean fold increase) time2/time1, as measured by HAI titres
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
GMFR (mean fold increase) time2/time1, as measured by HAI titres
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated
GMFR (mean fold increase) time2/time1, as measured by HAI titres
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated
GMFR (mean fold increase) time2/time1, as measured by HAI titres
Time frame: 21 days (18-28)
Number of Participants Reporting Adverse Event: Injection Site
Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising
Time frame: 7 days
Number of Participants Reporting Adverse Event: Systemic
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
Time frame: 7 days