InfluenzaNCT01282177
Influenza Vaccine Safety and Effectiveness in Healthcare Providers
An observational study of Influenza, run by Dalhousie University.
Trial summary
The overall objective of this study is to provide ongoing assessment of the safety and effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of Canadian HCP (Health care providers). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 1,143 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of adult HCP will be offered the opportunity to participate in this surveillance study at Influenza vaccination clinics in their health care facility
Who may be able to join
- 1)18-69 years old, inclusive, as of Sept. 1 on the year of enrolment; 2)understand the study, agree to its provisions, and give written informed consent to participate; 3)available for follow-up for at least 1 influenza season 4)have convenient access to a computer with internet access and basic skills for use of the internet; 5)employed full-or part -time (> 8 hours/week) in an acute care hospital (in any occupation) or, if a physician or midwife, working at least 8 hours per week in an acute care hospital.
Who cannot join
- planning to spend more than two consecutive weeks outside of Canada during the winter study period (Oct. 15- Apr. 15);
- received an immunoglobulin within 6 months of study entry;
- planning to take leave from work for more than two consecutive weeks during the winter study period (e.g. maternity or medical leave);
- participating in a trial that would result in receipt of an investigational medication during the study period
About this study
Official title: Monitoring Seasonal and Pandemic Vaccine Safety and Effectiveness in Healthcare Providers:A Prospective Cohort Study
The overall objective of this study is to provide ongoing assessment of the safety and effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of Canadian HCP (Health care providers). Given the uncertainties around the timing of the provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this study will focus on evaluation of safety and effectiveness of pandemic influenza immunization in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.
Read the detailed description
Participants in Year 1 (2009/10) will be recruited beginning Oct. 1 through the end of the pandemic H1N1 influenza immunization campaign.
Participants will be followed from the day of vaccination until the end of the influenza season approximately Oct-April for each season.
At the initial visit, participants will have 1 tube of blood (10cc) collected at the time of enrolment to determine baseline antibody titres against pandemic H1N1 and the influenza strains in the past and current year's seasonal influenza vaccines.
Participants will receive automated email reminders with links to follow-up web-based questionnaires at weekly intervals following the completion of the baseline survey and until the end of the influenza season.
If a participant reports a respiratory illness, they will receive a follow-up questionnaire asking details of the illness including the occurrence of respiratory illness and associated symptoms, contact with patients or household members that had respiratory illness, respiratory symptom-related healthcare utilization, prescription or over-the-counter products used for treatment of the respiratory illness, and number of days of work missed due to respiratory illness or worked with symptomatic respiratory tract infection. An email will be sent to each participant every Monday morning during the season reminding the participant to complete their weekly diary and report and send in their nasal swab if they have symptoms of an acute respiratory illness.
At the initial visit participants will be taught how to collect their nasal swab and will practice doing their own swab in the presence of the study nurse/research associate. Participants will be instructed to collect a nasal swab and return the swabs as soon as possible after onset of ILI or respiratory illness (target < 48h after onset). Participants will be asked to collect the swab if they develop symptoms compatible with a viral respiratory tract infection (fever without an apparent source OR new symptoms with at least 2 of the following -cough, runny/stuffy nose, sneezing, sore/scratchy throat, hoarseness, malaise, myalgia, headache, fatigue OR one local symptom (runny/stuffy nose, sneezing, sore/scratchy throat, hoarseness, cough) plus one systemic symptom (fever, malaise, myalgia, headache, fatigue). If they prefer, a nasopharyngeal swab will be collected by a member of the study team as soon as possible after the onset of symptoms.
- Conditions
- Influenza
- Keywords
- surveillance, safety , tolerability , vaccine
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and tolerability of seasonal and pandemic influenza vaccine among a cohort of HCP
Health care providers will receive automated email reminders with a link to report any changes in their health within 4 weeks of vaccination.
Measured: October to April each year
Secondary outcomes (1)
To validate published ILI case definitions in a cohort of HCP
A cohort of HCP will be asked via an automated email to report the presence of an upper respiratory illness and to self collect a nasal swab to be tested for influenza.
Measured: October to April each year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- PHAC/CIHR Influenza Research Network
- Responsible party
- Principal investigator, Shelly A. McNeil, Dalhousie University
- Investigators
- Shelly A McNeil, MD, Principal investigator, Dalhousie UniversityAllison McGeer, MD, Principal investigator, MOUNT SINAI HOSPITALAnne McCarthy, MD, Principal investigator, The Ottawa HospitalMark Loeb, MD, Principal investigator, Hamilton Health Sciences CenterGrant Stiver, MD, Principal investigator, Vancouver General HospitalBrenda Coleman, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282177
- Sponsor's protocol ID
- 114142
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2011
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Seasonal and Pandemic Vaccine Safety and Effectiveness in Healthcare Providers:A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01282177
- Acronym / sponsor ID
- 114142
- Conditions
- Influenza
- Keywords
- surveillance, safety , tolerability , vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,143 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- PHAC/CIHR Influenza Research Network
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to provide ongoing assessment of the safety and effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of Canadian HCP (Health care providers). Given the uncertainties around the timing of the provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this study will focus on evaluation of safety and effectiveness of pandemic influenza immunization in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.
Detailed description
Participants in Year 1 (2009/10) will be recruited beginning Oct. 1 through the end of the pandemic H1N1 influenza immunization campaign.
Participants will be followed from the day of vaccination until the end of the influenza season approximately Oct-April for each season.
At the initial visit, participants will have 1 tube of blood (10cc) collected at the time of enrolment to determine baseline antibody titres against pandemic H1N1 and the influenza strains in the past and current year's seasonal influenza vaccines.
Participants will receive automated email reminders with links to follow-up web-based questionnaires at weekly intervals following the completion of the baseline survey and until the end of the influenza season.
If a participant reports a respiratory illness, they will receive a follow-up questionnaire asking details of the illness including the occurrence of respiratory illness and associated symptoms, contact with patients or household members that had respiratory illness, respiratory symptom-related healthcare utilization, prescription or over-the-counter products used for treatment of the respiratory illness, and number of days of work missed due to respiratory illness or worked with symptomatic respiratory tract infection. An email will be sent to each participant every Monday morning during the season reminding the participant to complete their weekly diary and report and send in their nasal swab if they have symptoms of an acute respiratory illness.
At the initial visit participants will be taught how to collect their nasal swab and will practice doing their own swab in the presence of the study nurse/research associate. Participants will be instructed to collect a nasal swab and return the swabs as soon as possible after onset of ILI or respiratory illness (target < 48h after onset). Participants will be asked to collect the swab if they develop symptoms compatible with a viral respiratory tract infection (fever without an apparent source OR new symptoms with at least 2 of the following -cough, runny/stuffy nose, sneezing, sore/scratchy throat, hoarseness, malaise, myalgia, headache, fatigue OR one local symptom (runny/stuffy nose, sneezing, sore/scratchy throat, hoarseness, cough) plus one systemic symptom (fever, malaise, myalgia, headache, fatigue). If they prefer, a nasopharyngeal swab will be collected by a member of the study team as soon as possible after the onset of symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of adult HCP will be offered the opportunity to participate in this surveillance study at Influenza vaccination clinics in their health care facility
Key inclusion criteria (1 listed)
- 1)18-69 years old, inclusive, as of Sept. 1 on the year of enrolment; 2)understand the study, agree to its provisions, and give written informed consent to participate; 3)available for follow-up for at least 1 influenza season 4)have convenient access to a computer with internet access and basic skills for use of the internet; 5)employed full-or part -time (> 8 hours/week) in an acute care hospital (in any occupation) or, if a physician or midwife, working at least 8 hours per week in an acute care hospital.
Key exclusion criteria (4 listed)
- planning to spend more than two consecutive weeks outside of Canada during the winter study period (Oct. 15- Apr. 15);
- received an immunoglobulin within 6 months of study entry;
- planning to take leave from work for more than two consecutive weeks during the winter study period (e.g. maternity or medical leave);
- participating in a trial that would result in receipt of an investigational medication during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the safety and tolerability of seasonal and pandemic influenza vaccine among a cohort of HCP
Time frame: October to April each year
Health care providers will receive automated email reminders with a link to report any changes in their health within 4 weeks of vaccination.
1 secondary outcome
To validate published ILI case definitions in a cohort of HCP
Time frame: October to April each year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Shelly A McNeil, MD principal investigator
Dalhousie University
Allison McGeer, MD principal investigator
MOUNT SINAI HOSPITAL
Anne McCarthy, MD principal investigator
The Ottawa Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Dalhousie University.
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 1 inclusion and 4 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the safety and tolerability of seasonal and pandemic influenza vaccine among a cohort of HCP (time frame: October to April each year). 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 19 Jan 2017.