InfluenzaTITRE IINCT01067404
TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B
An observational study of Influenza, run by British Columbia Centre for Disease Control at 3 sites in Canada.
Trial summary
Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" \& "A/H3N2") and two kinds of influenza B ("B/Yamagata" \& "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. Read more about this study
- Who is it for?
- Ages 18 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2010to not given
- 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 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants of earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age)
Who may be able to join
- Child previously participated in the TITRE I study;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- Child has received the 2009 pandemic H1N1 influenza vaccine;
- Child is available and can complete all relevant procedures during the study period;
- Parent or legal guardian is available and can be reached by phone during the study period;
- Parent/guardian provides written informed consent;
- And, parent/guardian is fluent in English/French.
Who cannot join
- Child has already received the 2009-10 seasonal (TIV) influenza vaccine;
- Child has received immune globulin or other blood products within the prior six weeks;
- Child has received injected or oral steroids within prior six weeks;
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
- Or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec
Université Laval - Unité de recherche en santé publique
Québec, Quebec
BC Centre for Disease Control
Vancouver, British Columbia, V5Z4R4
About this study
Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" \& "A/H3N2") and two kinds of influenza B ("B/Yamagata" \& "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. The vaccine is changed from year to year, meaning it may include one kind of B virus one year and the other kind another year. But because influenza is so hard to predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is causing illness. The National Advisory Committee on Immunization recommends that all infants and toddlers receive influenza vaccine to protect against their high rates of hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two doses (prime plus boost) to have a good antibody response. If they have ever before received a single dose of influenza vaccine, then they are recommended to receive only one dose each year afterwards. But we don't know how well previous doses of one kind of influenza B set the stage for good antibody response to a single dose of the other kind of influenza B. This study will try to answer that question in a group of infants/toddlers who last year received two doses of one kind of B virus ("Yamagata"), as part of another study. This year, we will give them a single dose of influenza vaccine that now contains the other kind of B virus ("Victoria") and see how much antibody they make to both kinds. About half these children received a higher amount of influenza vaccine in the previous year's study, so we will also compare their antibody levels on that basis. Since influenza B is an illness especially of children, understanding how to best protect infants/toddlers against both kinds of influenza B is important. This study will help us know if we need to design a new vaccine that not only includes both kinds of influenza A, but also both kinds of influenza B.
- Conditions
- Influenza
- Being tested
- Trivalent inactivated influenza vaccine
- Keywords
- Influenza vaccines, Infant, Dose-Response relationship, immunologic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV)
| Study group | Role | What they receive |
|---|---|---|
| 2008-09 study TIV recipients | Infants and toddlers who participated in earlier clinical trial (TITRE) to evaluate dosing (0.25mL versus 0.5mL) of trivalent influenza vaccine (TIV) Receives: Biological: Trivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity based on CPMP criteria (seroprotection, defined as reciprocal HI titre equal to/greater than 40; seroconversion rate and factor) for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
Measured: 4-6 weeks after receipt of TIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Centre for Disease Control
- Sponsor type
- Other government
- Investigators
- Danuta M Skowronski, MD, Principal investigator, BC Centre for Disease Control, Vancouver, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067404
- Sponsor's protocol ID
- CIHR 200903CVC-203708/99971
- Acronym
- TITRE II
- Status last verified
- Feb 2010
- First submitted
- 10 Feb 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.
PubMed 21857263
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B
- ClinicalTrials.gov ID
- NCT01067404
- Acronym / sponsor ID
- TITRE II / CIHR 200903CVC-203708/99971
- Conditions
- Influenza
- Keywords
- Influenza vaccines, Infant, Dose-Response relationship, immunologic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British Columbia Centre for Disease ControlOther government
- Study start
- Feb 2010
- First posted
- 11 Feb 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.
Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" \& "A/H3N2") and two kinds of influenza B ("B/Yamagata" \& "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. The vaccine is changed from year to year, meaning it may include one kind of B virus one year and the other kind another year. But because influenza is so hard to predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is causing illness. The National Advisory Committee on Immunization recommends that all infants and toddlers receive influenza vaccine to protect against their high rates of hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two doses (prime plus boost) to have a good antibody response. If they have ever before received a single dose of influenza vaccine, then they are recommended to receive only one dose each year afterwards. But we don't know how well previous doses of one kind of influenza B set the stage for good antibody response to a single dose of the other kind of influenza B. This study will try to answer that question in a group of infants/toddlers who last year received two doses of one kind of B virus ("Yamagata"), as part of another study. This year, we will give them a single dose of influenza vaccine that now contains the other kind of B virus ("Victoria") and see how much antibody they make to both kinds. About half these children received a higher amount of influenza vaccine in the previous year's study, so we will also compare their antibody levels on that basis. Since influenza B is an illness especially of children, understanding how to best protect infants/toddlers against both kinds of influenza B is important. This study will help us know if we need to design a new vaccine that not only includes both kinds of influenza A, but also both kinds of influenza B.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2008-09 study TIV recipients | – | Biological: Trivalent inactivated influenza vaccineInfants and toddlers who participated in earlier clinical trial (TITRE) to evaluate dosing (0.25mL versus 0.5mL) of trivalent influenza vaccine (TIV) |
Who may qualify
- Ages
- 18 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants of earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age)
Key inclusion criteria (7 listed)
- Child previously participated in the TITRE I study;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- Child has received the 2009 pandemic H1N1 influenza vaccine;
- Child is available and can complete all relevant procedures during the study period;
- Parent or legal guardian is available and can be reached by phone during the study period;
Key exclusion criteria (5 listed)
- Child has already received the 2009-10 seasonal (TIV) influenza vaccine;
- Child has received immune globulin or other blood products within the prior six weeks;
- Child has received injected or oral steroids within prior six weeks;
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
- Or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.
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 |
|---|---|---|
| Trivalent inactivated influenza vaccine0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV) | Biological | 2008-09 study TIV recipients |
Primary outcome
Immunogenicity based on CPMP criteria (seroprotection, defined as reciprocal HI titre equal to/greater than 40; seroconversion rate and factor) for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
Time frame: 4-6 weeks after receipt of TIV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- Derived from this study: PubMed 21857263Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.
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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.
Danuta M Skowronski, MD principal investigator
BC Centre for Disease Control, Vancouver, Canada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by British Columbia Centre for Disease Control at 3 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Results are not available in the source record.
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?
Immunogenicity based on CPMP criteria (seroprotection, defined as reciprocal HI titre equal to/greater than 40; seroconversion rate and factor) for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses (time frame: 4-6 weeks after receipt of TIV). 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 NCT01067404, 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 11 Feb 2010.