Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
29 de outubro de 2015 atualizado por: Novartis
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
2719
Estágio
- Fase 2
- 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
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Florida
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Miami, Florida, Estados Unidos, 33143
- Miami Research Associates
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- Johnson County Clin-Trials
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
- Meridien Clinical Research
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New York
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Endwell, New York, Estados Unidos, 13760
- Regional Clinical Research
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Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, Inc
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North Carolina
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Cary, North Carolina, Estados Unidos, 27518
- Triangle Medical Research Associates
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Raleigh, North Carolina, Estados Unidos, 27609
- Triangle Medical Research Associates
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Carolina Medical Trials
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Ohio
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Franklin, Ohio, Estados Unidos, 45005
- Prestige Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- IPS Research
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16506
- West Ridge Family Practice (adult)
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Jefferson Hills, Pennsylvania, Estados Unidos, 15025
- Primary Physicians Research Inc. (adult)
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Rhode Island
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Warwick, Rhode Island, Estados Unidos, 02886
- Omega Clinical Research
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Texas
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Dallas, Texas, Estados Unidos, 75234
- Research Across America
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Houston, Texas, Estados Unidos, 77055
- West Houston Clinical Research Service
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Utah
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Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc./Foothill Family Clinic South
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Salt Lake City, Utah, Estados Unidos, 84109
- J.Lewis Research, Inc./Foothill Family Clinic
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Virginia
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Burke, Virginia, Estados Unidos, 22015
- Pi-Coor Clinical Research
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Fairfax, Virginia, Estados Unidos, 22030
- PI Coor Clinical Research
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Richmond, Virginia, Estados Unidos, 23219
- Virginia Commonwealth University
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Tlalpan, México, 14000
- Instituto Nacional de Ciencias
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- For additional entry criteria, please refer to protocol.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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Experimental: 30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
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8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
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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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Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Prazo: 21 days after each vaccination
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Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as participants having HI antibody titer ≥1:40.
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21 days after each vaccination
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Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Prazo: 21 days after each vaccination
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Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as participants having HI antibody titer ≥1:40.
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21 days after each vaccination
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Prazo: 21 days after each vaccination
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Geometric mean hemagglutinin inhibition (HI) titer = GMT
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21 days after each vaccination
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Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Prazo: 21 days after each vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria.
Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
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21 days after each vaccination
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Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Prazo: 21 days after each vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria.
Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
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21 days after each vaccination
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Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Prazo: 21 days after vaccination
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Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria.
Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
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21 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
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7 days after vaccination
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Novartis Vaccine and Diagnostics, Novartis
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 2009
Conclusão Primária (Real)
1 de novembro de 2009
Conclusão do estudo (Real)
1 de dezembro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de setembro de 2009
Primeira postagem (Estimativa)
9 de setembro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de dezembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de outubro de 2015
Última verificação
1 de outubro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V112_01
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