InfluenzaPhase 4NCT01000584
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
A Phase 4 study testing Arepanrix, Vaxigrip 2009/2010 in people with Influenza and H1N1 2009 Influenza, run by David Scheifele at 4 sites in Canada.
Trial summary
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, H1N1 2009 Influenza
- What is being tested?
- Arepanrix, Vaxigrip 2009/2010
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2009to Feb 2010
- Phase
- Phase 4
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Adults 20-59 years of age
Who cannot join
- Allergies to eggs, thimerosal, gentamicin sulphate, neomycin
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Chronic illness
Show all 10Show fewer
- Compromised immune system
- Previous lab-confirmed H1N12009 infection
- Receipt of H1N12009 vaccine
- Receipt of Seasonal Influenza vaccine since March 2009
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
McMaster University
Hamilton, Ontario
Kingston, Frontenac, Lanark Health Unit
Kingston, Ontario
Institut national de sante publique du Quebec
Québec, Quebec
University of Toronto, Mt Sinai Hospital
Toronto, Ontario
About this study
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.
Read the detailed description
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs.
- To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.
- Conditions
- Influenza, H1N1 2009 Influenza
- Being tested
- Arepanrix, Vaxigrip 2009/2010
- Keywords
- vaccine, H1N1, influenza, H1N1 influenza vaccine, influenza vaccine, seasonal Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arepanrix, Vaxigrip 2009/2010Biological
Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
Arepanrix, Vaxigrip 2009/2010Biological
Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently Receives: Biological: Arepanrix, Vaxigrip 2009/2010 |
| 2 | Other | Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine Receives: Biological: Arepanrix, Vaxigrip 2009/2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Measured: Day 7 and Day 21 post vaccination
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
Measured: Day 7 and Day 21 post vaccination
Secondary outcomes (1)
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Measured: Day 21 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Scheifele
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, David Scheifele, University of British Columbia
- Investigators
- David Scheifele, MD, Principal investigator, University of British ColumbiaAllison McGeer, MD, Study director, University of Toronto, Mt Sinai HospitalMark Loeb, MD, Study director, McMaster UniversityIan Gemmill, MD, Study director, Kingston, Frontenac, Lanark Health UnitMarc Dionne, MD, Study director, Institut national de sante publique du Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000584
- Sponsor's protocol ID
- H09-02811
- Status last verified
- Apr 2015
- First submitted
- 21 Oct 2009
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y; PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28.
PubMed 22652402
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
- ClinicalTrials.gov ID
- NCT01000584
- Acronym / sponsor ID
- H09-02811
- Conditions
- Influenza, H1N1 2009 Influenza
- Keywords
- vaccine, H1N1, influenza, H1N1 influenza vaccine, influenza vaccine, seasonal Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- David ScheifeleUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Oct 2009 (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 purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.
Detailed description
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs.
- To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: Arepanrix, Vaxigrip 2009/2010Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently |
| 2 | Other | Biological: Arepanrix, Vaxigrip 2009/2010Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent
- Adults 20-59 years of age
Key exclusion criteria (10 listed)
- Allergies to eggs, thimerosal, gentamicin sulphate, neomycin
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in 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 |
|---|---|---|
| Arepanrix, Vaxigrip 2009/2010Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently | Biological | 1 |
| Arepanrix, Vaxigrip 2009/2010Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix | Biological | 2 |
Primary outcome
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Time frame: Day 7 and Day 21 post vaccination
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
Time frame: Day 7 and Day 21 post vaccination
1 secondary outcome
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Time frame: Day 21 post vaccination
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 10 Apr 2015.
- Derived from this study: PubMed 22652402Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y; PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28.
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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.
David Scheifele, MD principal investigator
University of British Columbia
Allison McGeer, MD study director
University of Toronto, Mt Sinai Hospital
Mark Loeb, MD study director
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arepanrix, Vaxigrip 2009/2010 in people with Influenza and H1N1 2009 Influenza, run by David Scheifele at 4 sites 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 2 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Occurrence of adverse events (AEs) for days 0-6 after each vaccination (time frame: Day 7 and Day 21 post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000584, which also lists 1 linked publication.
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 10 Apr 2015.