InfluenzaPhase 4NCT01653015
Live Versus Inactivated Influenza Vaccine Study in Hutterite Children
A Phase 4 study testing Trivalent Inactivated Vaccine and Live Attenuated Influenza Vaccine in people with Influenza, run by McMaster University at 1 site in Canada.
Trial summary
There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. 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?
- Trivalent Inactivated Vaccine and Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,611 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2015
- 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 and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.
- other Hutterite community members that are not in Group A
Who cannot join
- anaphylactic reaction to a previous dose of LAIV or TIV
- known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- history of asthma
- medically diagnosed or treated wheezing within 42 days before enrollment
- Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
- anaphylactic reaction to gentamicin
Show all 14Show fewer
- anaphylactic reaction to gelatin
- anaphylactic reaction to neomycin
- anaphylactic reaction to arginine
- pregnancy
- household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
- use of aspirin or salicylate-containing products within 30 days before enrollment.
- Group B:
- 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 Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.
Read the detailed description
The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.
- Conditions
- Influenza
- Being tested
- Trivalent Inactivated Vaccine, Live Attenuated Influenza Vaccine
- 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 VaccineBiological
Also called VAXIGRIP by Sanofi Pasteur
Influenza vaccination, 0.5 ml dose 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 four weeks later.
Live Attenuated Influenza VaccineBiological
Also called FLUMIST by Mediummune.
Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine LAIV | Experimental | Live attenuated influenza vaccine (LAIV). Receives: Biological: Trivalent Inactivated Vaccine |
| Influenza vaccine TIV | Active comparator | Trivalent inactivated vaccine (TIV). Receives: Biological: Live Attenuated Influenza Vaccine |
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
Secondary outcomes (10)
Influenza like illness.
Measured: December to June each year for 3 years.
Physician diagnosed otitis media.
Measured: December to June each year for 3 years.
Antimicrobial prescriptions.
Measured: December to June each year for 3 years.
School or work related absenteeism.
Measured: December to June each year for 3 years.
Physician visits for respiratory illness.
Measured: December to June each year for 3 years.
Lower respiratory infection or pneumonia.
Measured: December to June each year for 3 years.
Hospitalization for lower respiratory infection or pneumonia.
Measured: December to June each year for 3 years.
All cause hospitalizations.
Measured: December to June each year for 3 years.
Deaths due to lower respiratory infections or pneumonia.
Measured: December to June each year for 3 years.
All cause deaths.
Measured: December to June each year for 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionDec 2015
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,611 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mark B Loeb, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653015
- Sponsor's protocol ID
- RC1-274129
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2012
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Loeb M, Russell ML, Manning V, Fonseca K, Earn DJ, Horsman G, Chokani K, Vooght M, Babiuk L, Schwartz L, Neupane B, Singh P, Walter SD, Pullenayegum E. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. 2016 Nov 1;165(9):617-624. doi: 10.7326/M16-0513. Epub 2016 Aug 16.
PubMed 27538259
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
- ClinicalTrials.gov ID
- NCT01653015
- Acronym / sponsor ID
- RC1-274129
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,611 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jul 2012 (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.
There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.
Detailed description
The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine LAIV | Experimental | Biological: Trivalent Inactivated VaccineLive attenuated influenza vaccine (LAIV). |
| Influenza vaccine TIV | Active comparator | Biological: Live Attenuated Influenza VaccineTrivalent inactivated vaccine (TIV). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.
- other Hutterite community members that are not in Group A
Key exclusion criteria (14 listed)
- anaphylactic reaction to a previous dose of LAIV or TIV
- known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- history of asthma
- medically diagnosed or treated wheezing within 42 days before enrollment
- Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
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 VaccineAlso: VAXIGRIP by Sanofi PasteurInfluenza vaccination, 0.5 ml dose 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 four weeks later. | Biological | Influenza vaccine LAIV |
| Live Attenuated Influenza VaccineAlso: FLUMIST by Mediummune.Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later. | Biological | Influenza vaccine TIV |
Primary outcome
Laboratory-confirmed influenza infection.
Time frame: up to 3 years
10 secondary outcomes
Influenza like illness.
Time frame: December to June each year for 3 years.
Physician diagnosed otitis media.
Time frame: December to June each year for 3 years.
Antimicrobial prescriptions.
Time frame: December to June each year for 3 years.
School or work related absenteeism.
Time frame: December to June each year for 3 years.
Physician visits for respiratory illness.
Time frame: December to June each year for 3 years.
Lower respiratory infection or pneumonia.
Time frame: December to June each year for 3 years.
Hospitalization for lower respiratory infection or pneumonia.
Time frame: December to June each year for 3 years.
All cause hospitalizations.
Time frame: December to June each year for 3 years.
Deaths due to lower respiratory infections or pneumonia.
Time frame: December to June each year for 3 years.
All cause deaths.
Time frame: December to June each year for 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 26 Oct 2018.
- Derived from this study: PubMed 27538259Loeb M, Russell ML, Manning V, Fonseca K, Earn DJ, Horsman G, Chokani K, Vooght M, Babiuk L, Schwartz L, Neupane B, Singh P, Walter SD, Pullenayegum E. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. 2016 Nov 1;165(9):617-624. doi: 10.7326/M16-0513. Epub 2016 Aug 16.
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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 B 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 Trivalent Inactivated Vaccine and Live Attenuated Influenza Vaccine 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 2 inclusion and 14 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 26 Oct 2018. 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 NCT01653015, 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 26 Oct 2018.