InfluenzaTITRE IIBNCT01235000
TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
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 29 to 51 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- 2010-11 trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 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 29 to 51 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants of an earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age) who later participated in 2009-10 study (TITRE II) to receive 2009-10 influenza vaccine
Who may be able to join
- Child previously participated in the TITRE II study;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- 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 2010-11 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, V5Z 4R4
About this study
Official title: TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
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. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.
- Conditions
- Influenza
- Being tested
- 2010-11 trivalent inactivated influenza vaccine
- Keywords
- Influenza vaccines, Infant, Dose-Response relationship, immunologic, Prime-boost response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2010-11 trivalent inactivated influenza vaccineBiological
A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| 2010-11 influenza vaccine recipients | Participants of an earlier clinical trial (TITRE II) to evaluate prime-boost response across B lineages in 2009-10 Receives: Biological: 2010-11 trivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
The seroprotection rate based on hemagglutination inhibition (HI) assay for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses following a single age-appropriate dose of 2010-11 TIV containing B/Brisbane/60/2008(Victoria)-like virus in young children originally primed with two doses of 2008-09 TIV containing B/Florida/4/2006(Yamagata) and who had received a single dose of the 2009-10 TIV containing B/Brisbane/60/2008(Victoria) virus
Measured: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)
Secondary outcomes (1)
Antibody response to other relevant TIV components
Other indicators of antibody response to each of the relevant TIV components will also be assessed
Measured: 4-6 weeks following a single dose of 2010-11 TIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startOct 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
- 30 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
- NCT01235000
- Sponsor's protocol ID
- CIHR 200903CVC-203708/99971a
- Acronym
- TITRE IIB
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2010
- Last updated
- 5 Nov 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 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
- ClinicalTrials.gov ID
- NCT01235000
- Acronym / sponsor ID
- TITRE IIB / CIHR 200903CVC-203708/99971a
- Conditions
- Influenza
- Keywords
- Influenza vaccines, Infant, Dose-Response relationship, immunologic, Prime-boost response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- British Columbia Centre for Disease ControlOther government
- Study start
- Oct 2010
- First posted
- 5 Nov 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. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2010-11 influenza vaccine recipients | – | Biological: 2010-11 trivalent inactivated influenza vaccineParticipants of an earlier clinical trial (TITRE II) to evaluate prime-boost response across B lineages in 2009-10 |
Who may qualify
- Ages
- 29 to 51 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants of an earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age) who later participated in 2009-10 study (TITRE II) to receive 2009-10 influenza vaccine
Key inclusion criteria (6 listed)
- Child previously participated in the TITRE II study;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- 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;
Key exclusion criteria (5 listed)
- Child has already received the 2010-11 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 |
|---|---|---|
| 2010-11 trivalent inactivated influenza vaccineA single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine | Biological | 2010-11 influenza vaccine recipients |
Primary outcome
The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
Time frame: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)
The seroprotection rate based on hemagglutination inhibition (HI) assay for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses following a single age-appropriate dose of 2010-11 TIV containing B/Brisbane/60/2008(Victoria)-like virus in young children originally primed with two doses of 2008-09 TIV containing B/Florida/4/2006(Yamagata) and who had received a single dose of the 2009-10 TIV containing B/Brisbane/60/2008(Victoria) virus
1 secondary outcome
Antibody response to other relevant TIV components
Time frame: 4-6 weeks following a single dose of 2010-11 TIV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
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.
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 6 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 5 Nov 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?
The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses (time frame: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (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 NCT01235000, 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 5 Nov 2010.