Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
11 februari 2016 bijgewerkt door: GlaxoSmithKline
European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
Studie Overzicht
Gedetailleerde beschrijving
Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine.
This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
Studietype
Observationeel
Inschrijving (Werkelijk)
11530
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Surrey, Verenigd Koninkrijk, GU2 7XH
- GSK Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 maanden en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Beschrijving
Inclusion Criteria:
- All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
- Pregnant women are also included in this study.
Exclusion Criteria:
• Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Study Cohort
Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted.
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Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Completeness of vaccination data in the computerized medical record system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of AEI reporting in the computerized medical record system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of vaccination data in the computerized medical record system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of AEI reporting in the computerized medical record system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of vaccination data in the card-based adverse event reporting system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of AEI reporting in the card-based adverse event reporting system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of vaccination data in the card-based adverse event reporting system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of AEI reporting in the card-based adverse event reporting system.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.
Tijdsspanne: Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2015
Primaire voltooiing (Werkelijk)
1 november 2015
Studie voltooiing (Werkelijk)
1 november 2015
Studieregistratiedata
Eerst ingediend
18 september 2015
Eerst ingediend dat voldeed aan de QC-criteria
1 oktober 2015
Eerst geplaatst (Schatting)
5 oktober 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
12 februari 2016
Laatste update ingediend die voldeed aan QC-criteria
11 februari 2016
Laatst geverifieerd
1 februari 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202055
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