Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
11. februar 2016 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
11530
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Surrey, Storbritannia, GU2 7XH
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Completeness of vaccination data in the computerized medical record system.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. oktober 2015
Primær fullføring (Faktiske)
1. november 2015
Studiet fullført (Faktiske)
1. november 2015
Datoer for studieregistrering
Først innsendt
18. september 2015
Først innsendt som oppfylte QC-kriteriene
1. oktober 2015
Først lagt ut (Anslag)
5. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202055
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