Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
11. února 2016 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
11530
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Surrey, Spojené království, GU2 7XH
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
6 měsíců a starší (Dítě, Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Completeness of vaccination data in the computerized medical record system.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2015
Primární dokončení (Aktuální)
1. listopadu 2015
Dokončení studie (Aktuální)
1. listopadu 2015
Termíny zápisu do studia
První předloženo
18. září 2015
První předloženo, které splnilo kritéria kontroly kvality
1. října 2015
První zveřejněno (Odhad)
5. října 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
12. února 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. února 2016
Naposledy ověřeno
1. února 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202055
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Klinické studie na Vaccine safety surveillance
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