Live Versus Inactivated Influenza Vaccine Study in Hutterite Children
25. oktober 2018 oppdatert av: McMaster University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
4611
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- McMaster University
-
-
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:
- healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.
Exclusion criteria:
- 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
- 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:
Inclusion Criteria
- other Hutterite community members that are not in Group A
Exclusion Criteria:
- there are no exclusion criteria for this category of participants
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: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Influenza vaccine LAIV
Live attenuated influenza vaccine (LAIV).
|
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.
Andre navn:
|
|
Aktiv komparator: Influenza vaccine TIV
Trivalent inactivated vaccine (TIV).
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Laboratory-confirmed influenza infection.
Tidsramme: up to 3 years
|
up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Influenza like illness.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Physician diagnosed otitis media.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Antimicrobial prescriptions.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
School or work related absenteeism.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Physician visits for respiratory illness.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Lower respiratory infection or pneumonia.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Hospitalization for lower respiratory infection or pneumonia.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
All cause hospitalizations.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
|
Deaths due to lower respiratory infections or pneumonia.
Tidsramme: December to June each year for 3 years.
|
December to June each year for 3 years.
|
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All cause deaths.
Tidsramme: December to June each year for 3 years.
|
December 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, MSc, 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.
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 (Faktiske)
1. november 2012
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
26. juli 2012
Først innsendt som oppfylte QC-kriteriene
27. juli 2012
Først lagt ut (Anslag)
30. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC1-274129
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