H1N1/2009 InfluenzaPhase 4NCT01001026
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
A Phase 4 study testing Arepanrix in people with H1N1/2009 Influenza, run by David Scheifele at 5 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 aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Read more about this study
- Who is it for?
- Ages 6 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- H1N1/2009 Influenza
- What is being tested?
- Arepanrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 5 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 6 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Good general health
- Written informed consent provided by or for the subject
- Aboriginal ethnicity (First Nations, Metis or Inuit)
- Adults 20-59 years of age
- Children 6-35 months of age
Who cannot join
- Allergies to eggs, thimerosal or gentamicin sulphate
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Compromised immune system
- Chronic illness
- Previous lab-confirmed H1N1/2009 infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Calgary Health Services and Alberta Children's Hospital
Calgary, Alberta
Capital Health District, Alberta Health Services
Edmonton, Alberta
Child and Family Research Center
Vancouver, British Columbia
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).
Read the detailed description
During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.
Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
- To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.
- Conditions
- H1N1/2009 Influenza
- Being tested
- Arepanrix
- Keywords
- vaccine, H1N1, influenza, H1N1 influenza vaccine, pandemic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArepanrixBiological
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
ArepanrixBiological
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Adults: One doses of H1N12009 vaccine Receives: Biological: Arepanrix |
| 2 | Other | Children: Two doses of H1N12009 vaccine given 3 weeks apart Receives: Biological: Arepanrix |
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)
Comparison of baseline and post-immunization antibody titres
Measured: Day 21 (adults) and Day 42 (children)
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 H1N1/2009 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Scheifele
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network
- Responsible party
- Sponsor-investigator, David Scheifele, University of British Columbia
- Investigators
- David Scheifele, MD, Principal investigator, University of British ColumbiaEthan Rubinstein, MD, Study director, University of Manitoba Health Sciences CentreGerald Predy, MD, Study director, Alberta Health Services, EdmontonLaura Sauve, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001026
- Sponsor's protocol ID
- H09-02769
- Status last verified
- Apr 2015
- First submitted
- 21 Oct 2009
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubinstein E, Predy G, Sauve L, Hammond GW, Aoki F, Sikora C, Li Y, Law B, Halperin S, Scheifele D. The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine. CMAJ. 2011 Sep 20;183(13):E1033-7. doi: 10.1503/cmaj.110196. Epub 2011 Jul 25.
PubMed 21788422
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 Aboriginal Children and Adults
- ClinicalTrials.gov ID
- NCT01001026
- Acronym / sponsor ID
- H09-02769
- Conditions
- H1N1/2009 Influenza
- Keywords
- vaccine, H1N1, influenza, H1N1 influenza vaccine, pandemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- David ScheifeleUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network
- 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 aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).
Detailed description
During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.
Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
- To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: ArepanrixAdults: One doses of H1N12009 vaccine |
| 2 | Other | Biological: ArepanrixChildren: Two doses of H1N12009 vaccine given 3 weeks apart |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Good general health
- Written informed consent provided by or for the subject
- Aboriginal ethnicity (First Nations, Metis or Inuit)
- Adults 20-59 years of age
- Children 6-35 months of age
Key exclusion criteria (8 listed)
- Allergies to eggs, thimerosal or gentamicin sulphate
- 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 |
|---|---|---|
| ArepanrixAdults: One dose Arepanrix vaccine given IM (0.5 mL) | Biological | 1 |
| ArepanrixChildren: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart | 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
Comparison of baseline and post-immunization antibody titres
Time frame: Day 21 (adults) and Day 42 (children)
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 21788422Rubinstein E, Predy G, Sauve L, Hammond GW, Aoki F, Sikora C, Li Y, Law B, Halperin S, Scheifele D. The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine. CMAJ. 2011 Sep 20;183(13):E1033-7. doi: 10.1503/cmaj.110196. Epub 2011 Jul 25.
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
Ethan Rubinstein, MD study director
University of Manitoba Health Sciences Centre
Gerald Predy, MD study director
Alberta Health Services, Edmonton
5 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 in people with H1N1/2009 Influenza, run by David Scheifele at 5 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 5 inclusion and 8 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 5 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 NCT01001026, 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.