- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00877396
Hutterite Influenza Prevention Study
Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
laboratory-confirmed influenza infection
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Influenza like illness
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Physician diagnosed otitis media
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
School or work related absenteeism
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Physician visits for respiratory illness
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Lower respiratory infection or pneumonia
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Hospitalizations for LRTI or pneumonia
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
All cause hospitalizations
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Deaths due to LRTI or pneumonia
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
All-cause deaths
Tidsram: Dec to June each year for 3 years
|
Dec to June each year for 3 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mark B Loeb, MD, McMaster University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MCT 88113
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