- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00192374
Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B,Live, Cold-Adapted (CAIV-T) in Healthy Children
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição
Estágio
- Fase 3
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
•who are aged at least 6 months and less than 36 months of age at the time of first vaccination
- who are in good health as determined by medical history, physical examination and clinical judgement
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
- who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (8 months ±1 month)
- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
Exclusion Criteria:
whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease
- with Down's syndrome or other known cytogenetic disorders
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (see Section 4.2.1)
- who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
- for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study
- have an immunosuppressed or an immunocompromised individual living in the same household
- who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)
- with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination or for which use is anticipated during the study
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results. If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Dobro
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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The primary efficacy endpoint was the first episode in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
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Medidas de resultados secundários
Medida de resultado |
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A secondary efficacy endpoint was the first episode of culture-confirmed influenza illness caused by any community-acquired antigenic subtype.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tawee Chotpitayasunondh, Dr., Queen Sirikit National Institute of Child Health (Children's Hospital)
- Investigador principal: Rosario Z. Capeding, Dr., Department of Microbiology, Research Institute for Tropical Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- D153-P513
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 .
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