InfluenzaPhase 2NCT03669627
CT18 Infant Influenza Priming Study in Vaccine Naive Infants
A Phase 2 study testing aTIV Primer, QIV Primer and aTIV Booster in people with Influenza, run by Canadian Immunization Research Network at 4 sites in Canada.
Trial summary
This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. 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?
- aTIV Primer, QIV Primer and aTIV Booster
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Nov 2018to 21 Jul 2021
- 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 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/LAR is willing and able to give informed consent for participation in the trial.
- Male or Female, aged six months to 23 months.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
Who cannot join
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
- Prior receipt of an influenza vaccine
- History of laboratory-confirmed influenza infection, by parent/LAR report
- Hypersensitivity to any vaccine component of products used in this study (see product monographs)
- Immunodeficiency or autoimmune disease
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Research Institute of the McGill University health Centre
Montreal, Quebec, H9H 4Y6
Équipe de recherche en vaccination CHU de Québec-Université Laval
Québec, Quebec, G1E 7G9
Vaccine Evaluation Center, BC Children's Hospital
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: A Randomized Controlled Observer Blind Trial to Compare the Immunogenicity and Acceptability of a MF59-adjuvanted Influenza Vaccine Compared to an Inactivated Influenza Vaccine as a Preferred Influenza Vaccine Priming Strategy for Naive Infants 6 to <24 Months of Age
This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine, either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent influenza vaccine (QIV). For the booster shot the following year, two thirds of participants will receive QIV and one third will receive MF59-adjuvanted vaccine.
Read the detailed description
Children under 24 months of age suffer from an influenza burden (high morbidity and mortality) similar to that of the elderly, and have been identified as a high priority target for vaccination programs by Canada's National Advisory Committee on Immunization. There is evidence that a person's first exposure to influenza antigens may have long-term implications for protection.
This is a randomized, controlled, observer-blind study that will assign participants to one of three groups. Group 1 will receive MF59-adjuvanted influenza vaccine (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 2 will receive QIV (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 3 will receive MF59-adjuvanted IV (two doses one month apart) in the fall of year 1, followed by MF59-adjuvanted IV (one dose) in the fall of year 2.
- Conditions
- Influenza
- Being tested
- aTIV Primer, QIV Primer, aTIV Booster, QIV Booster
- Keywords
- infants, priming, Fluad, Fluzone
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aTIV PrimerBiological
Also called FLUAD Pediatric®
MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
QIV PrimerBiological
Also called Fluzone® Quadrivalent
Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
aTIV BoosterBiological
Also called FLUAD Pediatric®
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
QIV BoosterBiological
Also called Fluzone® Quadrivalent
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1: aTIV primer, QIV booster | Active comparator | Two doses (0.25 mL) aTIV (FLUAD )received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2. Receives: Biological: aTIV Primer; Biological: QIV Booster |
| Group 2: QIV primer, QIV booster | Other | Standard of care control group:
Two doses (0.5 mL) QIV (Fluzone) received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2. Receives: Biological: QIV Primer; Biological: QIV Booster |
| Group 3: aTIV primer, aTIV booster | Experimental | This arm is experimental in that some participants will be receiving the MF59-adjuvanted TIV (FLUAD) in year two of the study, after the age of two years, which is off label.
Two doses (0.25 mL) TIV (FLUAD) received one month apart in year 1. One dose (0.25 mL) TIV (FLUAD) received as booster in year 2. Receives: Biological: aTIV Primer; Biological: aTIV Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hemagglutination inhibition (HI) antibody titers
Serum HI antibodies to influenza antigens A/H3N2, A/H1N1, and B Yamagata and Victoria lineages will be used to calculate the seroconversion rate and the seroprotection rates.
Measured: Before and after priming with the various vaccine combinations at day 393.
Secondary outcomes (1)
Adverse Events (AEs)
Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.
Measured: Days 0 to 545
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Nov 2018
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three groups: Group 1 will receive aTIV as a primer and QIV as a booster, Group 2 will receive QIV as both primer and booster, and Group 3 will receive aTIV as both primer and booster.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunization Research Network
- Sponsor type
- Research network
- Collaborators
- Provincial Health Services Authority British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Université de Montréal, Canadian Center for Vaccinology, CHU de Quebec-Universite Laval, Dalhousie University
- Responsible party
- Principal investigator, Joanne Langley, Canadian Immunization Research Network
- Investigators
- Joanne M Langley, MD, Principal investigator, Dalhousie University, Canadian Center for VaccinologySoren Gantt, MD, PhD, Principal investigator, BC Children's Hospital, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669627
- Sponsor's protocol ID
- CT18
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Observer Blind Trial to Compare the Immunogenicity and Acceptability of a MF59-adjuvanted Influenza Vaccine Compared to an Inactivated Influenza Vaccine as a Preferred Influenza Vaccine Priming Strategy for Naive Infants 6 to <24 Months of Age
- ClinicalTrials.gov ID
- NCT03669627
- Acronym / sponsor ID
- CT18
- Conditions
- Influenza
- Keywords
- infants, priming, Fluad, Fluzone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Canadian Immunization Research NetworkResearch network
- Collaborators
- Provincial Health Services Authority British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Université de Montréal, Canadian Center for Vaccinology, CHU de Quebec-Universite Laval, Dalhousie University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine, either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent influenza vaccine (QIV). For the booster shot the following year, two thirds of participants will receive QIV and one third will receive MF59-adjuvanted vaccine.
Detailed description
Children under 24 months of age suffer from an influenza burden (high morbidity and mortality) similar to that of the elderly, and have been identified as a high priority target for vaccination programs by Canada's National Advisory Committee on Immunization. There is evidence that a person's first exposure to influenza antigens may have long-term implications for protection.
This is a randomized, controlled, observer-blind study that will assign participants to one of three groups. Group 1 will receive MF59-adjuvanted influenza vaccine (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 2 will receive QIV (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 3 will receive MF59-adjuvanted IV (two doses one month apart) in the fall of year 1, followed by MF59-adjuvanted IV (one dose) in the fall of year 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups: Group 1 will receive aTIV as a primer and QIV as a booster, Group 2 will receive QIV as both primer and booster, and Group 3 will receive aTIV as both primer and booster.
| Arm | Type | Receives |
|---|---|---|
| Group 1: aTIV primer, QIV booster | Active comparator | Biological: aTIV Primer, Biological: QIV BoosterTwo doses (0.25 mL) aTIV (FLUAD )received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2. |
| Group 2: QIV primer, QIV booster | Other | Biological: QIV Primer, Biological: QIV BoosterStandard of care control group: Two doses (0.5 mL) QIV (Fluzone) received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2. |
| Group 3: aTIV primer, aTIV booster | Experimental | Biological: aTIV Primer, Biological: aTIV BoosterThis arm is experimental in that some participants will be receiving the MF59-adjuvanted TIV (FLUAD) in year two of the study, after the age of two years, which is off label. Two doses (0.25 mL) TIV (FLUAD) received one month apart in year 1. One dose (0.25 mL) TIV (FLUAD) received as booster in year 2. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent/LAR is willing and able to give informed consent for participation in the trial.
- Male or Female, aged six months to 23 months.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
Key exclusion criteria (6 listed)
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
- Prior receipt of an influenza vaccine
- History of laboratory-confirmed influenza infection, by parent/LAR report
- Hypersensitivity to any vaccine component of products used in this study (see product monographs)
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 |
|---|---|---|
| aTIV PrimerAlso: FLUAD Pediatric®MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart | Biological | Group 1: aTIV primer, QIV booster, Group 3: aTIV primer, aTIV booster |
| QIV PrimerAlso: Fluzone® QuadrivalentUnadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart | Biological | Group 2: QIV primer, QIV booster |
| aTIV BoosterAlso: FLUAD Pediatric®MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2 | Biological | Group 3: aTIV primer, aTIV booster |
| QIV BoosterAlso: Fluzone® QuadrivalentUnadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2 | Biological | Group 1: aTIV primer, QIV booster, Group 2: QIV primer, QIV booster |
Primary outcome
Serum hemagglutination inhibition (HI) antibody titers
Time frame: Before and after priming with the various vaccine combinations at day 393.
Serum HI antibodies to influenza antigens A/H3N2, A/H1N1, and B Yamagata and Victoria lineages will be used to calculate the seroconversion rate and the seroprotection rates.
1 secondary outcome
Adverse Events (AEs)
Time frame: Days 0 to 545
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 28 Mar 2023.
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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 M Langley, MD principal investigator
Dalhousie University, Canadian Center for Vaccinology
Soren Gantt, MD, PhD principal investigator
BC Children's Hospital, UBC
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 aTIV Primer, QIV Primer and aTIV Booster in people with Influenza, run by Canadian Immunization Research Network 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 3 inclusion and 6 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 28 Mar 2023. 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?
Serum hemagglutination inhibition (HI) antibody titers (time frame: Before and after priming with the various vaccine combinations at day 393.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.