Seasonal InfluenzaPhase 2NCT01180621
Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children
A Phase 2 study testing Fluviral in people with Seasonal Influenza, run by Dalhousie University at 4 sites in Canada.
Trial summary
The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time. Read more about this study
- Who is it for?
- Ages 12 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Fluviral
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 2
- 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 12 to 59 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.
- Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel including by telephone).
- Age 12-59 months at Visit 1, male or female
- Receipt of one or two doses of Arepanrix (adjuvanted H1N12009 vaccine, GlaxoSmithKline (GSK)) in 2009 documented by written record or attested by a confident personal recollection (window for vaccination will be 1 October 2009 to January 31, 2010).
Who cannot join
- Systemic hypersensitivity to hens' eggs or to any other Fluviral S/F vaccine component such as thimerosal
- History of a life-threatening reaction to any influenza vaccine
- Receipt of Arepanrix after January 31st , 2010
- Receipt of non-study TIV (Trivalent Influenza Vaccine)for the 2010-2011 season
- Receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of study entry or planned administration of any non-study vaccines during the study period
- Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection
Show all 10Show fewer
- Receipt of blood or any blood-derived products within the past 3 months
- Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
- Immune compromise as a result of a medical condition, transplantation or immunosuppressive medication, not including topical or aerosol medications
- Participation in any other research study involving a non-approved drug or medical device
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
ACHIEVE Research, Alberta Children's Hospital
Calgary, Alberta
Candian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec
Vaccine Evaluation Center
Vancouver, British Columbia
About this study
Official title: PCIRN Evaluation of Seasonal Trivalent Influenza Vaccine for 2010-2011 in Young Children in the First Year After the H1N1 Pandemic
The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time.
The seasonal influenza vaccine for this fall will be a trivalent inactivated product (regular seasonal influenza vaccine)once again, without adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could result in more frequent side-effects. However, there is no good evidence that pre-existing immunity to a strain in the vaccine does increase side-effects. In short, there could be nothing out of the ordinary this fall but it would be prudent to check this before public flu vaccination programs begin.
Read the detailed description
This study will assess the safety of seasonal influenza vaccination in children who received one or two doses of the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus and immune responses to the seasonal vaccine. It will be carried out before the new vaccine is released for general use so that we have an accurate picture of vaccine safety and responses for other Canadians.
A total of 200 children (50 at each site) 12-59 month olds, are being asked to participate in this study. A research nurse will conduct a telephone screening with potential participants to determine if they are eligible for the study. Volunteers must have had one or two doses of the adjuvanted H1N1 vaccine before January 31, 2010. To eligible participants do not need a previous years seasonal flu vaccine(TIV)however, this will be recorded.
The study involves 1-2 vaccination visits 28 days apart. Those children who have not received a previous dose of TIV will receive a second dose at visit # 2. After each vaccination, there will be contacts 1 and 7 days later for a description of any symptoms experienced. A blood sample will be requested at at each study visit (2 or 3 visits depending on previous TIV history) to measure immune responses to the seasonal vaccine.
The study will take 21-42 days to complete, depending upon whether or not the child received a previous dose of seasonal TIV vaccination. The 4 study sites are in Vancouver, Calgary, Montreal and Halifax.
Each subject's parent will be asked to keep daily notes of any changes at the injection site (pain, redness, swelling) and any general symptoms (such as irritability, drowsiness, decreased appetite, sleep disturbance,sweating and shivering, including your axilla or rectal temperature, for 7 days after each vaccination. Major health changes will be assessed for 21 days post vaccination.
- Conditions
- Seasonal Influenza
- Being tested
- Fluviral
- Keywords
- vaccine, Seasonal Influenza Vaccine, Influenza Vaccine, Vaccine Safety, Vaccine Immunogenicity, Fluviral 2010-2011
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluviralBiological
Also called Influenza Virus Vaccine, Trivalent, Inactivated, Split Virion, Prepared in Eggs
0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age
| Study group | Role | What they receive |
|---|---|---|
| Fluviral | Experimental | 0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age Receives: Biological: Fluviral |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV)
Assessing reactogenicity on days 1-6 following TIV administration.
Measured: 7 days
Secondary outcomes (1)
To measure immune response to each component of TIV.
Determining if there is a relationship between pre-TIV influenza haemagglutinin titers (ie, 6 to 10 months after receipt of adjuvanted vaccine), post TIV titers, and reactogenicity following TIV receipt.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionApr 2011
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 Seasonal 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre, Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Investigators
- Joanne Langley, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180621
- Sponsor's protocol ID
- PCIRN RT-07
- Status last verified
- Jun 2011
- First submitted
- 11 Aug 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Langley JM, Scheifele DW, Quach C, Vanderkooi OG, Ward B, McNeil S, Dobson S, Kellner JD, Kuhn S, Kollman T, MacKinnon-Cameron D, Smith B, Li Y, Halperin SA. Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine. 2012 May 14;30(23):3389-94. doi: 10.1016/j.vaccine.2012.03.046. Epub 2012 Mar 30.
PubMed 22469860
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCIRN Evaluation of Seasonal Trivalent Influenza Vaccine for 2010-2011 in Young Children in the First Year After the H1N1 Pandemic
- ClinicalTrials.gov ID
- NCT01180621
- Acronym / sponsor ID
- PCIRN RT-07
- Conditions
- Seasonal Influenza
- Keywords
- vaccine, Seasonal Influenza Vaccine, Influenza Vaccine, Vaccine Safety, Vaccine Immunogenicity, Fluviral 2010-2011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- IWK Health Centre, Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Aug 2010 (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 seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time.
The seasonal influenza vaccine for this fall will be a trivalent inactivated product (regular seasonal influenza vaccine)once again, without adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could result in more frequent side-effects. However, there is no good evidence that pre-existing immunity to a strain in the vaccine does increase side-effects. In short, there could be nothing out of the ordinary this fall but it would be prudent to check this before public flu vaccination programs begin.
Detailed description
This study will assess the safety of seasonal influenza vaccination in children who received one or two doses of the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus and immune responses to the seasonal vaccine. It will be carried out before the new vaccine is released for general use so that we have an accurate picture of vaccine safety and responses for other Canadians.
A total of 200 children (50 at each site) 12-59 month olds, are being asked to participate in this study. A research nurse will conduct a telephone screening with potential participants to determine if they are eligible for the study. Volunteers must have had one or two doses of the adjuvanted H1N1 vaccine before January 31, 2010. To eligible participants do not need a previous years seasonal flu vaccine(TIV)however, this will be recorded.
The study involves 1-2 vaccination visits 28 days apart. Those children who have not received a previous dose of TIV will receive a second dose at visit # 2. After each vaccination, there will be contacts 1 and 7 days later for a description of any symptoms experienced. A blood sample will be requested at at each study visit (2 or 3 visits depending on previous TIV history) to measure immune responses to the seasonal vaccine.
The study will take 21-42 days to complete, depending upon whether or not the child received a previous dose of seasonal TIV vaccination. The 4 study sites are in Vancouver, Calgary, Montreal and Halifax.
Each subject's parent will be asked to keep daily notes of any changes at the injection site (pain, redness, swelling) and any general symptoms (such as irritability, drowsiness, decreased appetite, sleep disturbance,sweating and shivering, including your axilla or rectal temperature, for 7 days after each vaccination. Major health changes will be assessed for 21 days post vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluviral | Experimental | Biological: Fluviral0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent provided for the subject by a parent or legal guardian.
- Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel including by telephone).
- Age 12-59 months at Visit 1, male or female
- Receipt of one or two doses of Arepanrix (adjuvanted H1N12009 vaccine, GlaxoSmithKline (GSK)) in 2009 documented by written record or attested by a confident personal recollection (window for vaccination will be 1 October 2009 to January 31, 2010).
Key exclusion criteria (10 listed)
- Systemic hypersensitivity to hens' eggs or to any other Fluviral S/F vaccine component such as thimerosal
- History of a life-threatening reaction to any influenza vaccine
- Receipt of Arepanrix after January 31st , 2010
- Receipt of non-study TIV (Trivalent Influenza Vaccine)for the 2010-2011 season
- Receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of study entry or planned administration of any non-study vaccines 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluviralAlso: Influenza Virus Vaccine, Trivalent, Inactivated, Split Virion, Prepared in Eggs0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age | Biological | Fluviral |
Primary outcome
To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV)
Time frame: 7 days
Assessing reactogenicity on days 1-6 following TIV administration.
1 secondary outcome
To measure immune response to each component of TIV.
Time frame: 42 days
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 22 Jun 2011.
- Derived from this study: PubMed 22469860Langley JM, Scheifele DW, Quach C, Vanderkooi OG, Ward B, McNeil S, Dobson S, Kellner JD, Kuhn S, Kollman T, MacKinnon-Cameron D, Smith B, Li Y, Halperin SA. Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine. 2012 May 14;30(23):3389-94. doi: 10.1016/j.vaccine.2012.03.046. Epub 2012 Mar 30.
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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.
Joanne Langley, MD principal investigator
Dalhousie University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluviral in people with Seasonal Influenza, run by Dalhousie University 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 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 22 Jun 2011. 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 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?
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?
To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV) (time frame: 7 days). 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 NCT01180621, 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 22 Jun 2011.