InfluenzaPhase 3TITRENCT00710866
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
A Phase 3 study testing Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) in people with Influenza, run by British Columbia Centre for Disease Control at 5 sites in Canada.
Trial summary
The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
- Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
- Child is available and can complete all relevant procedures during the entire study period
- Parent or legal guardian is available and can be reached by phone during the entire study period
- Parent/guardian provides written informed consent
- Parent/guardian is fluent in English
Who cannot join
- Child has history of laboratory-confirmed influenza
- Child has history of any prior influenza immunization
- Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
- Child has received immune globulin or other blood products within the prior six weeks
- Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
- Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
Show all 9Show fewer
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
- Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
- Child has a 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
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Study site
Coquitlam, British Columbia, V3C 4J2
Dalhousie University / IWK Health Centre
Halifax, Nova Scotia
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, H9H4Y6
Université de Laval - Unité de recherche en santé publique
Québec, Quebec
Vaccine Evaluation Centre
Vancouver, British Columbia
About this study
The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.
- Conditions
- Influenza
- Being tested
- Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)
- 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.
Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)Biological
Also called VAXIGRIP®
Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 doses 0.5mL VAXIGRIP® at months 0, 1 Receives: Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) |
| 2 | Active comparator | 2 doses 0.25mL VAXIGRIP® at months 0, 1 Receives: Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
Seroprotection rate: HI titers =>40
Measured: 27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
Seroprotection rate: HI titers =>40
Measured: 27-46 days after the second dose
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
Seroprotection rate: HI titers =>40
Measured: 27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
Seroprotection rate: HI titers =>40
Measured: 27-46 days after the second dose
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
Measured: 27-46 days after the second dose
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
Seroprotection rate: HI titers =>40
Measured: 27-46 days after the second dose
Adverse Events: Fever After Either Dose - Infants 6-11 Months
Fever defined as temperature >= 38 C
Measured: 3 days after immunization
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
Fever defined as temperature >= 38 C
Measured: 3 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710866
- Sponsor's protocol ID
- PHAC 6273-15-2008/4160872
- Acronym
- TITRE
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2008
- Last updated
- 4 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 21857263Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.
PubMed 21768314
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
- ClinicalTrials.gov ID
- NCT00710866
- Acronym / sponsor ID
- TITRE / PHAC 6273-15-2008/4160872
- Conditions
- Influenza
- Keywords
- Influenza Vaccines, Infant, Dose-Response Relationship, Immunologic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- British Columbia Centre for Disease ControlOther government
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 4 Aug 2011
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 antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)2 doses 0.5mL VAXIGRIP® at months 0, 1 |
| 2 | Active comparator | Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)2 doses 0.25mL VAXIGRIP® at months 0, 1 |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
- Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
- Child is available and can complete all relevant procedures during the entire study period
- Parent or legal guardian is available and can be reached by phone during the entire study period
- Parent/guardian provides written informed consent
Key exclusion criteria (9 listed)
- Child has history of laboratory-confirmed influenza
- Child has history of any prior influenza immunization
- Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
- Child has received immune globulin or other blood products within the prior six weeks
- Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
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 |
|---|---|---|
| Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)Also: VAXIGRIP®Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France. | Biological | 1, 2 |
Primary outcome
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
Time frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
Time frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
Time frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
Time frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
Time frame: 27-46 days after the second dose
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
Time frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
Adverse Events: Fever After Either Dose - Infants 6-11 Months
Time frame: 3 days after immunization
Fever defined as temperature >= 38 C
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
Time frame: 3 days after immunization
Fever defined as temperature >= 38 C
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 21768314Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) in people with Influenza, run by British Columbia Centre for Disease Control 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 6 inclusion and 9 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 4 Aug 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1) (time frame: 27-46 days after the second dose). The study lists 8 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 NCT00710866, which also lists 2 linked publications.
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 4 Aug 2011.