InfluenzaPhase 4NCT01000831
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
A Phase 4 study testing adjuvanted Arepanrix in people with Influenza, run by University of British Columbia at 6 sites in Canada.
Trial summary
The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- adjuvanted Arepanrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 6 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 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent provided for the subject by a parent or legal guardian
- Children age 6-35 months
Who cannot join
- Allergies to eggs, thimerosal, gentamicin sulphate or latex
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Chronic illness that could interfere with trial participation
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
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Children's Hospital, University of Calgary
Calgary, Alberta
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia
McGill University Health Center - Vaccine Study Center
Montreal, Quebec
Unité de Recherche en Santé Publique (CHUQ)
Québec, Quebec
Child and Family Research Institute
Vancouver, British Columbia
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia
About this study
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.
Read the detailed description
The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.
The objectives of this study are two-fold:
- To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
- To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.
- Conditions
- Influenza
- Being tested
- adjuvanted Arepanrix
- Keywords
- vaccine, influenza, H1N1 influenza vaccine, influenza vaccine, Arepanrix
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvanted ArepanrixBiological
Also called Influenza vaccine
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Adjuvanted Arepanrix 2 doses | Active comparator | Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart Receives: Biological: adjuvanted Arepanrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immunogenicity of one and two doses Arepanrix
To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age
Measured: Day 7 and Day 21 post vaccination measured at day 42
Rapid Trial
To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible
Measured: Day 42
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network
- Responsible party
- Sponsor
- Investigators
- David Scheifele, MD, Principal investigator, University of British ColumbiaMarc Dionne, MD, Study director, Unité de Recherche en Santé Publique (CHUQ)Brian Ward, MD, Principal investigator, McGill University Health Center - Vaccine Study CenterJoanne Langley, MD, Study director, Canadian Center for Vaccinology, Dalhousie UniversityOtto Vanderkooi, MD, Study director, Alberta Children's Hospital, University of CalgarySimon Dobson, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000831
- Sponsor's protocol ID
- H09-02749
- Status last verified
- Apr 2015
- First submitted
- 21 Oct 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33.
PubMed 21178654
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
- ClinicalTrials.gov ID
- NCT01000831
- Acronym / sponsor ID
- H09-02749
- Conditions
- Influenza
- Keywords
- vaccine, influenza, H1N1 influenza vaccine, influenza vaccine, Arepanrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, 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 compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.
Detailed description
The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.
The objectives of this study are two-fold:
- To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
- To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvanted Arepanrix 2 doses | Active comparator | Biological: adjuvanted ArepanrixTwo doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Written informed consent provided for the subject by a parent or legal guardian
- Children age 6-35 months
Key exclusion criteria (10 listed)
- Allergies to eggs, thimerosal, gentamicin sulphate or latex
- 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 |
|---|---|---|
| adjuvanted ArepanrixAlso: Influenza vaccineTwo doses of adjuvanted Arepanrix vaccine given 3 weeks apart | Biological | Adjuvanted Arepanrix 2 doses |
Primary outcome
Safety and immunogenicity of one and two doses Arepanrix
Time frame: Day 7 and Day 21 post vaccination measured at day 42
To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age
Rapid Trial
Time frame: Day 42
To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible
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 15 Apr 2015.
- Results publication: PubMed 21178654Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33.
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.
David Scheifele, MD principal investigator
University of British Columbia
Marc Dionne, MD study director
Unité de Recherche en Santé Publique (CHUQ)
Brian Ward, MD principal investigator
McGill University Health Center - Vaccine Study Center
6 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 adjuvanted Arepanrix in people with Influenza, run by University of British Columbia at 6 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 15 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 6 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?
Safety and immunogenicity of one and two doses Arepanrix (time frame: Day 7 and Day 21 post vaccination measured at day 42). 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 NCT01000831, 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 15 Apr 2015.