Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
18 de setembro de 2018 atualizado por: GlaxoSmithKline
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study.
The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
Tipo de estudo
Intervencional
Inscrição (Real)
957
Estágio
- Fase 3
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
-
-
-
Mengshan Town, China
- GSK Investigational Site
-
-
Guangxi
-
Wuzhou, Guangxi, China
- GSK Investigational Site
-
-
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
1 ano a 2 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
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
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age.
Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
|
Single dose, intramuscular administration
Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
|
|
Comparador Ativo: Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
|
Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Prazo: One month after Poliorix™ booster vaccination.
|
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50).
This outcome measure concerns subjects in the Poliorix Group only.
|
One month after Poliorix™ booster vaccination.
|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Prazo: Before booster vaccination.
|
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
|
Before booster vaccination.
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Prazo: One month after Poliorix™ booster vaccination.
|
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs).
This outcome measure concerns subjects in the Poliorix Group only.
|
One month after Poliorix™ booster vaccination.
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Prazo: Before booster vaccination.
|
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
|
Before booster vaccination.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Prazo: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
|
Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = Cry when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
This outcome measure concerns subjects in the Poliorix Group only.
|
Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Prazo: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
|
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)].
Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine.
Grade 3 drowsiness = drowsiness that prevented normal activities.
Grade 3 fever = fever (axillary temperature) >39.0°C.
Grade 3 irritability = crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Related = symptom assessed by the investigator as causally related to the vaccination.
This outcome measure concerns subjects in the Poliorix Group only.
|
Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Prazo: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study.
Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
This outcome measure concerns subjects in the Poliorix Group only.
|
Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Prazo: During the entire study period (Day 0 to Month 1).
|
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
|
During the entire study period (Day 0 to Month 1).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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
25 de abril de 2011
Conclusão Primária (Real)
19 de setembro de 2011
Conclusão do estudo (Real)
19 de setembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
24 de março de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de março de 2011
Primeira postagem (Estimativa)
25 de março de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de setembro de 2018
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 114306
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dados/documentos do estudo
-
Especificação do conjunto de dados
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de dados de participantes individuais
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Relatório de Estudo Clínico
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulário de Consentimento Informado
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Plano de Análise Estatística
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocolo de estudo
Identificador de informação: 114306Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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 .