- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02567721
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
11 de fevereiro de 2016 atualizado por: 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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
11530
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Surrey, Reino Unido, GU2 7XH
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 meses e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Completeness of vaccination data in the computerized medical record system.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2015
Conclusão Primária (Real)
1 de novembro de 2015
Conclusão do estudo (Real)
1 de novembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
18 de setembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de outubro de 2015
Primeira postagem (Estimativa)
5 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de fevereiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de fevereiro de 2016
Última verificação
1 de fevereiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202055
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