Hutterite Influenza Prevention Study
27 de septiembre de 2011 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
4771
Fase
- Fase 4
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Comparador de placebos: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
laboratory-confirmed influenza infection
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Influenza like illness
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Physician diagnosed otitis media
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
School or work related absenteeism
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Physician visits for respiratory illness
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Lower respiratory infection or pneumonia
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Hospitalizations for LRTI or pneumonia
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
All cause hospitalizations
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
Deaths due to LRTI or pneumonia
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
|
All-cause deaths
Periodo de tiempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark B Loeb, MD, McMaster University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2008
Finalización primaria (Actual)
1 de mayo de 2011
Finalización del estudio (Actual)
1 de julio de 2011
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2009
Primero enviado que cumplió con los criterios de control de calidad
6 de abril de 2009
Publicado por primera vez (Estimar)
7 de abril de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de septiembre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
27 de septiembre de 2011
Última verificación
1 de septiembre de 2011
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCT 88113
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