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Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)

11. februar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

11530

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Vaccine safety surveillance
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 navne:
  • Dataindsamling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
- 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.
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
- 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.
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
- 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.
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
- 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.
Up to 3 months (between 1 September 2015 and 30 November 2015)

Sekundære resultatmål

Resultatmål
Tidsramme
Completeness of vaccination data in the computerized medical record system.
Tidsramme: Up to 3 months (between 1 September 2015 and 30 November 2015)
Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the computerized medical record system.
Tidsramme: Up to 3 months (between 1 September 2015 and 30 November 2015)
Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the computerized medical record system.
Tidsramme: Up to 3 months (between 1 September 2015 and 30 November 2015)
Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the computerized medical record system.
Tidsramme: Up to 3 months (between 1 September 2015 and 30 November 2015)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)
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)
Up to 3 months (between 1 September 2015 and 30 November 2015)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Samarbejdspartnere

University of Surrey

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

18. september 2015

Først indsendt, der opfyldte QC-kriterier

1. oktober 2015

Først opslået (Skøn)

5. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202055

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Kliniske forsøg med Influenza

Kliniske forsøg med Vaccine safety surveillance

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner