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InfluenzaPhase 4NCT00877396

Hutterite Influenza Prevention Study

A Phase 4 study testing Influenza vaccination and Hepatitis A Vaccine in people with Influenza, run by McMaster University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. 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?
Influenza vaccination and Hepatitis A Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,771 participants
Where
No sites listed yet
Study dates
Sep 2008to Jul 2011
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

  • Hutterites other than the healthy children who will be immunized. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups:
  • individuals aged ≥ 65 years
  • children 23 months of age or less
  • anyone with ≥ 1 of the following conditions severe enough to require regular medical follow-up or hospital care:
  • chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma)
  • diabetes mellitus and other metabolic diseases
Show all 14Show fewer
  • cancer
  • immunodeficiency
  • immunosuppression (due to underlying disease and/or therapy)
  • renal disease
  • anemia
  • hemoglobinopathy
  • any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration.
  • Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.

Who cannot join

  • There are no exclusion criteria for this category of participants.
  • Group B:
  • Anaphylactic reaction to a previous dose of influenza vaccine
  • Anaphylactic reaction to hepatitis A vaccine
  • Anaphylactic reaction to neomycin
  • Known 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.

About this study

Official title: Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial

The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.

Read the detailed description

Colonies will be enrolled in September 2008.

Healthy Hutterite Children will be vaccinated in October, in each year of the study (2008, 2009, \& 2010)

Influenza Surveillance phase will begin around December-January of each year.

  • All study outcomes will be collected during the Surveillance phase of the study from Dec to June for 3 years.
  • Outcomes will be collected when research nurses visit the colonies. A research nurse will visit enrolled colonies twice a week during the surveillance phase and review study diaries and obtain swabs from participants with symptoms of influenza.
Conditions
Influenza
Being tested
Influenza vaccination, Hepatitis A 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.

  • Influenza vaccinationBiological

    Also called Vaxigrip by Sanofi Pasteur

    Influenza vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose (0.5 mL) 4 weeks later.

  • Hepatitis A VaccineBiological

    Also called Avaxim Pediatric by Sanofi Pasteur

    Hepatitis vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose ( saline- 0.5 mL) 4 weeks later.

Study groups in NCT00877396
Study groupRoleWhat they receive
InfluenzaExperimentalInactivated Influenza vaccination
Receives: Biological: Influenza vaccination
ControlPlacebo comparatorHepatitis A vaccine
Receives: Biological: Hepatitis A Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. laboratory-confirmed influenza infection

    Measured: Dec to June each year for 3 years

Secondary outcomes (9)

  1. Influenza like illness

    Measured: Dec to June each year for 3 years

  2. Physician diagnosed otitis media

    Measured: Dec to June each year for 3 years

  3. School or work related absenteeism

    Measured: Dec to June each year for 3 years

  4. Physician visits for respiratory illness

    Measured: Dec to June each year for 3 years

  5. Lower respiratory infection or pneumonia

    Measured: Dec to June each year for 3 years

  6. Hospitalizations for LRTI or pneumonia

    Measured: Dec to June each year for 3 years

  7. All cause hospitalizations

    Measured: Dec to June each year for 3 years

  8. Deaths due to LRTI or pneumonia

    Measured: Dec to June each year for 3 years

  9. All-cause deaths

    Measured: Dec 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.

  1. First posted7 Apr 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2011
  4. Study completionJul 2011

Resources

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
4,771 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00877396
Sponsor's protocol ID
MCT 88113
Status last verified
Sep 2011
First submitted
22 Jan 2009
Last updated
28 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang B, Russell ML, Moss L, Fonseca K, Earn DJ, Aoki F, Horsman G, Caeseele PV, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD, Loeb M. Effect of Influenza Vaccination of Children on Infection Rate in Hutterite Communities: Follow-Up Study of a Randomized Trial. PLoS One. 2016 Dec 15;11(12):e0167281. doi: 10.1371/journal.pone.0167281. eCollection 2016.

    PubMed 27977707

  • Loeb M, Russell ML, Fonseca K, Webby R, Walter SD. Comparison of multiple estimates of efficacy for influenza vaccine. Vaccine. 2011 Dec 9;30(1):1-4. doi: 10.1016/j.vaccine.2011.10.069. Epub 2011 Nov 7.

    PubMed 22098676

  • Loeb M, Russell ML, Moss L, Fonseca K, Fox J, Earn DJ, Aoki F, Horsman G, Van Caeseele P, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD. Effect of influenza vaccination of children on infection rates in Hutterite communities: a randomized trial. JAMA. 2010 Mar 10;303(10):943-50. doi: 10.1001/jama.2010.250.

    PubMed 20215608

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Influenza vaccination and Hepatitis A Vaccine in people with Influenza, run by McMaster University.

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 14 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 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: Dec to June each year for 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 NCT00877396, which also lists 3 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 28 Sep 2011.

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