InfluenzaPhase 1/2NCT02263040
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV
A Phase 1/2 study testing Fluzone High-Dose and Fluzone (standard dose) in people with Influenza, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone High-Dose and Fluzone (standard dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to 31 Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers
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.
Read the 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
- Being tested
- Fluzone High-Dose, Fluzone (standard dose)
- Keywords
- influenza vaccine, adult, immunogenicity, reactogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone High-DoseBiological
Influenza vaccine
Fluzone (standard dose)Biological
Influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Fluzone High-Dose |
| 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 Receives: Biological: Fluzone (standard dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 21 days post-vaccination (18-28)
Secondary outcomes (7)
Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay
Measured: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
GMFR (mean fold increase) time2/time1, as measured by HAI titres
Measured: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
GMFR (mean fold increase) time2/time1, as measured by HAI titres
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison J McGeer, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263040
- Sponsor's protocol ID
- 14-0909
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2014
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Following publication of results
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers
- ClinicalTrials.gov ID
- NCT02263040
- Acronym / sponsor ID
- 14-0909
- Conditions
- Influenza
- Keywords
- influenza vaccine, adult, immunogenicity, reactogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Fluzone | Experimental | Biological: Fluzone High-DoseFluzone 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 | Biological: 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone High-DoseInfluenza vaccine | Biological | High Dose Fluzone |
| Fluzone (standard dose)Influenza vaccine | Biological | Fluzone (standard dose) |
Primary outcome
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.
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
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
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
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
7 secondary outcomes
Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated
Time frame: 21 days (18-28)
Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated
Time frame: 21 days (18-28)
Number of Participants Reporting Adverse Event: Injection Site
Time frame: 7 days
Number of Participants Reporting Adverse Event: Systemic
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Following publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison J McGeer, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluzone High-Dose and Fluzone (standard dose) in people with Influenza, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Seroconversion to A/California/07/2009 (H1N1) (time frame: 21 days (18-28)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.