- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00877396
Hutterite Influenza Prevention Study
Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
|
Comparatore placebo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
laboratory-confirmed influenza infection
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Influenza like illness
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Physician diagnosed otitis media
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
School or work related absenteeism
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Physician visits for respiratory illness
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Lower respiratory infection or pneumonia
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Hospitalizations for LRTI or pneumonia
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
All cause hospitalizations
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Deaths due to LRTI or pneumonia
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
All-cause deaths
Lasso di tempo: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Mark B Loeb, MD, McMaster University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCT 88113
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Influenza vaccination
-
Centre National de la Recherche Scientifique, FranceUniversité Paris-Dauphine; Fondation La main à la pâte; Direction de l Évaluation...CompletatoConoscenza della salute, atteggiamenti, pratica | Esitazione vaccinale | Rifiuto del vaccinoFrancia