InfluenzaPhase 4NCT02871206
Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
A Phase 4 study testing Fluad and Fluzone in people with Influenza, run by McMaster University at 1 site in Canada.
Trial summary
This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluad and Fluzone
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,425 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Jul 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Healthy children aged 6 months to 72 months
- household and extended family members of children in Group A
- extended family is defined as the household members of the grandparents of the children in Group A
- other Hutterite community members that are not in Group A
Who cannot join
- Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components
- Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- Guillain- Barré syndrome within eight weeks of a previous influenza vaccine
- Use of aspirin or salicylate- containing products within 30 days before enrollment
- Group B:
- there are no exclusion criteria for this category of participants
- Group C:
- there are no exclusion criteria for this category of participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.
- Conditions
- Influenza
- Being tested
- 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.
FluadBiological
FluzoneBiological
| Study group | Role | What they receive |
|---|---|---|
| Adjuvanted Influenza Vaccine | Experimental | Fluad. A 0.25 ml intramuscular dose of the vaccine will be administered to children aged from 6 months to less than 36 months and a 0.5ml dose will be administered to children aged from 36 months to 6 years. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.25 ml dose of the vaccine four weeks following the first vaccine as per influenza immunization recommendations if they are aged between 6 months and less than 36 months or a second dose of 0.5ml if they are aged from 36 months to 6 years. Receives: Biological: Fluad |
| Quadrivalent Influenza Vaccine | Active comparator | Fluzone. A 0.5 ml dose of the vaccine will be administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose of the influenza vaccine four weeks following the first vaccine as per influenza immunization recommendations. Receives: Biological: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed influenza infection
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionJul 2019
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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,425 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, MD, MSc., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871206
- Sponsor's protocol ID
- AV-IIV
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
Publications
Switzer C, Verschoor CP, Pullenayegum E, Singh P, Loeb M. Adjuvant-attenuated symptom severity of influenza infections in vaccinated children. Infect Med (Beijing). 2022 Sep 15;1(3):163-170. doi: 10.1016/j.imj.2022.09.002. eCollection 2022 Sep.
PubMed 38077624
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
- ClinicalTrials.gov ID
- NCT02871206
- Acronym / sponsor ID
- AV-IIV
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,425 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of Calgary, University of Saskatchewan
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 18 Aug 2016 (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.
This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.
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 |
|---|---|---|
| Adjuvanted Influenza Vaccine | Experimental | Biological: FluadFluad. A 0.25 ml intramuscular dose of the vaccine will be administered to children aged from 6 months to less than 36 months and a 0.5ml dose will be administered to children aged from 36 months to 6 years. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.25 ml dose of the vaccine four weeks following the first vaccine as per influenza immunization recommendations if they are aged between 6 months and less than 36 months or a second dose of 0.5ml if they are aged from 36 months to 6 years. |
| Quadrivalent Influenza Vaccine | Active comparator | Biological: FluzoneFluzone. A 0.5 ml dose of the vaccine will be administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose of the influenza vaccine four weeks following the first vaccine as per influenza immunization recommendations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- -Healthy children aged 6 months to 72 months
- household and extended family members of children in Group A
- extended family is defined as the household members of the grandparents of the children in Group A
- other Hutterite community members that are not in Group A
Key exclusion criteria (8 listed)
- Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components
- Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- Guillain- Barré syndrome within eight weeks of a previous influenza vaccine
- Use of aspirin or salicylate- containing products within 30 days before enrollment
- there are no exclusion criteria for this category of participants
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 |
|---|---|---|
| Fluad | Biological | Adjuvanted Influenza Vaccine |
| Fluzone | Biological | Quadrivalent Influenza Vaccine |
Primary outcome
Laboratory-confirmed influenza infection
Time frame: Up to 3 years
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 21 Nov 2024.
- Derived from this study: PubMed 38077624Switzer C, Verschoor CP, Pullenayegum E, Singh P, Loeb M. Adjuvant-attenuated symptom severity of influenza infections in vaccinated children. Infect Med (Beijing). 2022 Sep 15;1(3):163-170. doi: 10.1016/j.imj.2022.09.002. eCollection 2022 Sep.
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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.
Mark Loeb, MD, MSc. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluad and Fluzone in people with Influenza, run by McMaster University at 1 site 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 8 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Laboratory-confirmed influenza infection (time frame: Up to 3 years). 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 NCT02871206, 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 21 Nov 2024.