Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
29 de octubre de 2015 actualizado 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
2719
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Novartis Vaccine and Diagnostics, Novartis
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2009
Finalización primaria (Actual)
1 de noviembre de 2009
Finalización del estudio (Actual)
1 de diciembre de 2010
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2009
Publicado por primera vez (Estimar)
9 de septiembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
29 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- V112_01
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