Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
6 de março de 2015 atualizado por: GlaxoSmithKline
Case-control Study to Evaluate the Vaccine Effectiveness of RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.
Visão geral do estudo
Status
Retirado
Condições
Intervenção / Tratamento
Descrição detalhada
The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.
No vaccine will be administered during this study.
Tipo de estudo
Observacional
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
2 meses a 5 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
Descrição
Inclusion Criteria:
For SGE subjects:
- A male or female child aged 12 weeks to < 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
- Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
- Onset of SGE ≤ 14 days prior to admission/ ED stay.
- Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.
For Cases:
• Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
For Controls:
- Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
- Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
- Subjects born within ± 2 weeks from the date of birth of the case.
Exclusion Criteria:
For SGE subjects:
- Child in care.
- Hospitalisation is unrelated to GE.
- Onset of SGE > 48 hours after admission to (or ED stay at) the hospital.
- Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
- Subject with immunodeficiency.
- Subjects who live out of the federative entity where hospital(s) are located.
For Controls:
• Subject has previously participated as case in this study.
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?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Cases
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory.
|
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED.
Stool samples will be tested to determine the presence or absence of rotavirus (RV).
Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
|
|
Controls
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay.
|
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED.
Stool samples will be tested to determine the presence or absence of rotavirus (RV).
Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.
Prazo: At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
|
At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
|
|
Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
|
Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
Prazo: During hospitalisation and after discharge (approximately 12 months from study initiation).
|
During hospitalisation and after discharge (approximately 12 months from study initiation).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 dezembro de 2014
Conclusão Primária (Antecipado)
1 de dezembro de 2015
Conclusão do estudo (Antecipado)
1 de dezembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
31 de outubro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de outubro de 2013
Primeira postagem (Estimativa)
7 de novembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
9 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 116494
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .