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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Fluzone | Experimental | 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 |
|
| Fluzone (standard dose) | Active Comparator | Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg hemagglutinin per virus strain for adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone High-Dose | Biological | Influenza vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 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 | 21 days post-vaccination (18-28) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison J McGeer, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
Following publication of results
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 HA per virus strain Fluzone High-Dose: Influenza vaccine Either 2014/15 OR 2015/16 |
| FG001 | Fluzone (Standard Dose) | Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg HA per virus strain for adults Fluzone (standard dose): Influenza vaccine Either: 2014/15 OR 2015/16 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Fluzone | Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain Fluzone High-Dose: Influenza vaccine |
| BG001 | Fluzone (Standard Dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A blood sample from one participant was hemolysed and not available for analysis | Posted | Count of Participants | Participants | 21 days (18-28) |
|
6 months
Daily diary for 7 days Nursing note at day 21 Asked to report to clinic for 6 months after vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Fluzone | Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain Fluzone High-Dose: Influenza vaccine Either season: 2014/15 OR 2015/16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | General disorders | MedDRA (10.0) | Non-systematic Assessment | Moderate or extreme: interfered with, or prevented, daily activities |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison McGeer | Mount Sinai Hospital, Toronto | 416-586-3118 | allison.mcgeer@sinaihealthsystem.ca |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000618615 | Fluzone High-Dose |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Fluzone (standard dose) |
| Biological |
Influenza vaccine |
|
GMFR (mean fold increase) time2/time1, as measured by HAI titres
| 21 days (18-28) |
| Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012 | 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 | 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 | GMFR (mean fold increase) time2/time1, as measured by HAI titres | 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 | 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 | 7 days |
Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults
Fluzone (standard dose): Influenza vaccine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Underlying chronic medical condition | Count of Participants | Participants |
|
Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults
Fluzone (standard dose): Influenza vaccine
Either season: 2014/15 OR 2015/16
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 21 days post vaccination (18-28) |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 21 days post-vaccination (18-28) |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 21 days post vaccination (18-28) |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 21 days post-vaccination (18-28) |
|
|
|
| Secondary | Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1) | GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay | Posted | Geometric Mean | 95% Confidence Interval | fold ratio | 21 days (18-28) |
|
|
|
| Secondary | Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013 | GMFR (mean fold increase) time2/time1, as measured by HAI titres | Posted | Geometric Mean | 95% Confidence Interval | fold ratio | 21 days (18-28) |
|
|
|
| Secondary | Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012 | GMFR (mean fold increase) time2/time1, as measured by HAI titres | Posted | Geometric Mean | 95% Confidence Interval | fold ratio | 21 days (18-28) |
|
|
|
| Secondary | Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated | GMFR (mean fold increase) time2/time1, as measured by HAI titres | Posted | Geometric Mean | 95% Confidence Interval | fold ratio | 21 days (18-28) |
|
|
|
| Secondary | Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated | GMFR (mean fold increase) time2/time1, as measured by HAI titres | Posted | Geometric Mean | 95% Confidence Interval | fold ratio | 21 days (18-28) |
|
|
|
| Secondary | 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 | All participants were able to provide data | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 7 days |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 26 |
| 87 |
| EG001 | Fluzone (Standard Dose) | Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults Fluzone (standard dose): Influenza vaccine Either season: 2014/15 OR 2015/16 | 0 | 83 | 0 | 83 | 6 | 83 |
|
| Headache | General disorders | MedDRA (10.0) | Non-systematic Assessment | Moderate or extreme: interfered with, or prevented, daily activities |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment | Moderate or extreme: interfered with, or prevented, daily activities |
|
| Malaise | General disorders | MedDRA (10.0) | Non-systematic Assessment | Moderate or extreme: interfered with, or prevented, daily activities |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| moderate |
|
| Moderate |
|
| Extreme |
|