Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
17 de novembro de 2014 atualizado por: Sanofi Pasteur, a Sanofi Company
Safety and Immunogenicity of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age.
Primary Objective:
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago.
Secondary Objective:
- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population.
Observational Objective:
- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
All participants will receive one dose of Menactra vaccine at their first clinic visit.
There will be a telephone safety follow-up contact at six months post-vaccination.
Tipo de estudo
Intervencional
Inscrição (Real)
834
Estágio
- Fase 2
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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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
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California
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San Diego, California, Estados Unidos, 92103
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
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Crestview Hills, Kentucky, Estados Unidos, 41017
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Massachusetts
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Spokane, Massachusetts, Estados Unidos, 99202
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Woburn, Massachusetts, Estados Unidos, 01801
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Michigan
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Niles, Michigan, Estados Unidos, 49120
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Stevensville, Michigan, Estados Unidos, 49127
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New York
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Rochester, New York, Estados Unidos, 14618
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Ohio
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Cleveland, Ohio, Estados Unidos, 44121
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Pennsylvania
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Sellersville, Pennsylvania, Estados Unidos, 18960
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
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Utah
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Layton, Utah, Estados Unidos, 84041
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Orem, Utah, Estados Unidos, 84057
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Virginia
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Midlothian, Virginia, Estados Unidos, 23113
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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
15 anos a 55 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Received Menactra 4 to 6 years prior to enrollment, at an age ≥11 years, and is < 56 years of age on the day of enrollment.
- Informed consent form has been signed and dated by the subject or by the subject and the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. Females who are pre-menarche or post-menopausal for at least 1 year, or surgically sterile will not be excluded.
- Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- History of documented invasive meningococcal disease.
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.
- Suspected or known hypersensitivity to latex or to any of the components of Menactra vaccine, or history of a life-threatening reaction to Menactra vaccine or to a vaccine containing any of the same substances.
- Receipt of any meningococcal vaccine since receipt of a single dose of Menactra vaccine 4-6 years prior to enrollment.
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the Day 28 visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- History of laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject.
- Personal history of Guillain-Barré syndrome (GBS).
- Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
- Receipt of oral or injectable antibiotic therapy within the 72 hours prior to the first blood draw.
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed 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
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Meningococcal vaccine Group
Participants must have received Menactra vaccine 4 to 6 years prior to enrollment
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0,5 ml, intramuscular
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 Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Prazo: Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
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Day 28 post-vaccination
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Prazo: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Prazo: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Prazo: Day 6 and Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).
Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
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Day 6 and Day 28 post-vaccination
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Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Prazo: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).
Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
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Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
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Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Prazo: Day 6 and Day 28 post-vaccination
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Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).
Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
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Day 6 and Day 28 post-vaccination
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Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Prazo: Day 0 up to Day 7 post-vaccination
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Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm.
Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.
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Day 0 up to Day 7 post-vaccination
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
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 setembro de 2011
Conclusão Primária (Real)
1 de junho de 2012
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
26 de setembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de setembro de 2011
Primeira postagem (Estimativa)
28 de setembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de novembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de novembro de 2014
Última verificação
1 de novembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MTA77
- U1111-1117-7012 (Outro identificador: WHO)
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