- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01421251
H1N1 Vaccine Safety in Manitoba, Canada
The Safety of GSK Biological's H1N1 Pandemic Vaccine in Manitoba, Canada
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The objective of this study is to examine the safety of the H1N1 vaccine administered in Manitoba during the second wave of the pandemic (Oct 2009-Mar 2010) by describing the age sex specific and age standardized incidence rates of certain vaccination adverse events in the vaccinated populations during the first 6 months of follow-up and to compare the rates with those in the non-vaccinated population and the general Manitoba population.
Study design The proposed study will be a retrospective analysis of population based cohorts of subjects whose vaccination status and health events before and after H1N1 vaccination are recorded in various Manitoba databases. All H1N1 vaccinated and unvaccinated individuals are eligible to be included in the study population. There will be no exclusion criteria. The list of specific adverse events of special interest (AESIs) includes: anaphylaxis, Bell's palsy, convulsions, demyelination, encephalitis, Guillain-Barré syndrome, neuritis, vasculitis and various pregnancy outcomes.
Vaccinated individuals will be identified using the Manitoba Immunization Monitoring System (MIMS). Unvaccinated individuals will be identified using the Population Registry. AESIs and other clinically relevant information will be determined using hospital, physician claim and DPIN databases.
The primary statistical analysis will be a comparison of the overall and age specific rates of deaths and AESIs in the vaccinated cohort relative to the non-vaccinated cohort. The two cohorts will be matched on age (month and year of birth), sex and postal code of residence. The analyses will be stratified by specific subgroups: (e.g. pregnant women, persons who are immune suppressed or with autoimmune disorders).
The observed number of events will be determined from the date of first vaccination for each subject and the matched control until the first occurrence of a specific event. Information on events for each person will be derived from the medical claims and hospitalization databases. The person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. Incidence rate ratios and 95% confidence intervals will be calculated by comparing the standardized incidence rates in the vaccinated cohort with those in the matched non vaccinated cohort.
In addition, the observed number of deaths and AESIs in the total vaccinated population and in specific subgroups (as above) will be compared to the expected numbers based on the age sex specific rates in the general Manitoba population. Similar to the matched cohort component, the observed number of events will be determined for the vaccinated individuals from the date of first vaccination until the first occurrence of a specific event, and the person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. The background rate of targeted events will be calculated utilizing information from the mortality, physician claims and hospitalization databases for the total population in Manitoba for the period 2004 2008. Since the risk of some of the events is low, calculating the age sex specific rates based on five years of data will increase the stability of the rates. The expected number of events will be calculated by multiplying the person years at risk by the age sex specific background rate of each targeted event. Standardized incidence ratios (SIRs) or mortality ratios (SMRs) will be calculated as the number of observed events over the number of expected events, with 95% confidence intervals. To assess the absolute burden of an eventual excess in observed number of events the absolute difference between the observed and expected number of events for certain AESIs will also be calculated.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3B 3P5
- International Centre for Infectious Diseases
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- All 6-month or older Manitoba residents are eligible
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Matched cohorts - population based
Two cohorts: vaccinated individuals are matched to unvaccinated individuals on the basis of age, sex, and postal code of residence.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adverse Effects of H1N1 vaccination
Délai: One year
|
Incidence rate ratios of certain vaccination adverse effects
|
One year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence Ratios of Adverse Effects
Délai: One year
|
Standardized incidence ratios of certain adverse events in relation to history of H1N1 vaccination.
|
One year
|
Sex-specific adverse effects of vaccination
Délai: One year
|
Determination of sex-specific adverse effects following H1N1 vaccination.
|
One year
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Salah Mahmud, M.D., Ph.D., University of Manitoba
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ICID-2011-H1N1-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Grippe H1N1
-
Mitsubishi Tanabe Pharma CorporationComplété
-
Fraunhofer, Center for Molecular BiotechnologyWalter Reed Army Institute of Research (WRAIR); Defense Advanced Research...Complété
-
Canadian Critical Care Trials GroupCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated... et autres collaborateursRésilié
-
PHAC/CIHR Influenza Research NetworkGlaxoSmithKline; CHU de Quebec-Universite Laval; The Ottawa Hospital; Hamilton... et autres collaborateursComplété
-
Butantan InstituteUniversity of Sao Paulo; Insituto Adolfo Lutz; Centro de Referencia e Treinamento...ComplétéPatients immunodéprimés | Innocuité du vaccin contre la grippe pandémique A (H1N1) | Immunogénicité du vaccin contre la grippe pandémique A (H1N1)Brésil
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Pamela... et autres collaborateursComplété
-
National Taiwan University HospitalInconnueAnalyse sérologique | Nouvelle vaccination contre la grippe H1N1 | Patients en hémato-oncologie pédiatriqueTaïwan
-
Medical University of GrazComplétéInfection H1N1 cliniquement suspectéeL'Autriche
-
Chang Gung Memorial HospitalComplétéHypoxémie | Pneumonie H1N1
-
The University Clinic of Pulmonary and Allergic...Complété