Hutterite Influenza Prevention Study
27. september 2011 oppdatert av: Mark Loeb, McMaster University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
4771
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Group A:
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- There are no exclusion criteria for this category of participants.
Group B:
Inclusion Criteria:
- Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Influenza
Inactivated Influenza vaccination
|
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.
Andre navn:
|
|
Placebo komparator: Control
Hepatitis A vaccine
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
laboratory-confirmed influenza infection
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Influenza like illness
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Physician diagnosed otitis media
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
School or work related absenteeism
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Physician visits for respiratory illness
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Lower respiratory infection or pneumonia
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Hospitalizations for LRTI or pneumonia
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
All cause hospitalizations
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Deaths due to LRTI or pneumonia
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
All-cause deaths
Tidsramme: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark B Loeb, MD, McMaster University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2008
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
22. januar 2009
Først innsendt som oppfylte QC-kriteriene
6. april 2009
Først lagt ut (Anslag)
7. april 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. september 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2011
Sist bekreftet
1. september 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MCT 88113
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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