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

11. Februar 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

11530

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Monate und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.
Andere Namen:
  • Datensammlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Completeness of vaccination data in the computerized medical record system.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Up to 3 months (between 1 September 2015 and 30 November 2015)
Up to 3 months (between 1 September 2015 and 30 November 2015)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Mitarbeiter

University of Surrey

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2015

Primärer Abschluss (Tatsächlich)

1. November 2015

Studienabschluss (Tatsächlich)

1. November 2015

Studienanmeldedaten

Zuerst eingereicht

18. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Oktober 2015

Zuerst gepostet (Schätzen)

5. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 202055

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