Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
16 de junio de 2014 actualizado por: Novartis Vaccines
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older
The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older.
The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
7109
Fase
- 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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Bogota
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Avenida Carrera 68, Bogota, Colombia
- 209, Centro de Investigacion CAFAM
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Carrera 42A, Bogota, Colombia, 1750
- 206, Centro de Atencion e Investigacion Medica CAIMED
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Carrera 42A, Bogota, Colombia, 1750
- 213, Centro de Atencion e Investigacion Medica CAIMED
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Cra 14 No Piso Sexto, Bogota, Colombia
- 207, Centro de Investigacion Cafesalud Medicina Prepagada
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Arizona
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Phoenix, Arizona, Estados Unidos, 85253
- 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
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Florida
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Deland, Florida, Estados Unidos, 32720
- 318 Avail Clinical Research, 860 Peachwood Drive
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Jacksonville, Florida, Estados Unidos, 32205
- 306 Westside Center for Clinical Research, 810 Lane Avenue South
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Miami, Florida, Estados Unidos, 33143
- 328 Miami Research Associates, 6141 Sunset Drive
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- 320 Johnson County Clin-Trials, 15602 College Blvd
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Newton, Kansas, Estados Unidos, 67114
- 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
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Wichita, Kansas, Estados Unidos, 67205
- 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
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Wichita, Kansas, Estados Unidos, 67207
- 322 Heartland Research Associates Wichita, 1709 S. Rock Road
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63104
- 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
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Saint Louis, Missouri, Estados Unidos, 63141
- 330 Mercy Health Research, 12680 Olive Blvd Suite 200
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89130
- 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
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New York
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Endwell, New York, Estados Unidos, 13760
- 311 Regional Clinical Research INC, 415 Hooper Road
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27612
- 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
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Winston-Salem, North Carolina, Estados Unidos, 27103
- 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
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Ohio
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Franklin, Ohio, Estados Unidos, 45005
- 303 Prestige Clinical Research, 333 Conover Drive
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Rhode Island
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Warwick, Rhode Island, Estados Unidos, 02886
- 325 Omega Medical Research, 400 Bald Hill Road
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- 312 Spartanburg Regional Medical Center, 485 Simuel Road
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Utah
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Jordan, Utah, Estados Unidos
- 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
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Salt Lake City, Utah, Estados Unidos, 84109
- 317 J. Lewis Research Inc., 2295 Foothill Drive
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Salt Lake City, Utah, Estados Unidos, 84121
- 305 Foothill Family Clinic South, 6360 South 3000 East
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Virginia
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Fairfax, Virginia, Estados Unidos, 22030
- 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
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Pasay City, Filipinas, 1300
- 110, San Juan de Dios Hospital, 2772 Roxas Blvd
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Quezon City, Filipinas, 1102
- 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
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Cavite
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DBB B Dasmarinas, Cavite, Filipinas, 4114
- 103, De La Salle Health Sciences Institute
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Dbbb Dasmarinas, Cavite, Filipinas, 4114
- 102, De La Salle Health Sciences Institute
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Manila
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Ermita, Manila, Filipinas, 1000
- 105, Manila Doctors Hospital, 667 United Nations Avenue
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Mesa, Manila, Filipinas, 1016
- 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
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Rizal Avenue Avenida Cruz, Manila, Filipinas, 1003
- 104 Jose Reyes Memorial Medical Center
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Taft Avenue, Manila, Filipinas, 1000
- 107 Philippine General Hospital
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Muntinlupa
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Corporate City Alabang, Muntinlupa, Filipinas, 1781
- 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
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Corporate City Alabang, Muntinlupa, Filipinas
- 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
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Rosa City
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City Health Office 1, Rosa City, Filipinas, 4026
- 108, City Health Office 1 Rosa City
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Clayton ciudad del Saber Edificio 118, Panamá
- 203, Health Research International HRI
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Consultorios Royal Center 108, Panamá
- 205, Medical and Research Center Calle 53 Urbanizacion Marbella
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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
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.
Exclusion Criteria:
- Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
- Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
- Known or suspected impairment/alteration of immune function.
- Individuals with a known bleeding diathesis.
- History of Guillain-Barré syndrome.
- Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
- Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
- Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
- Individuals who had received vaccination against seasonal influenza in the previous 6 months.
- Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Individuals providing consent who did not consent to the retention of their serum samples after study completion.
- Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
- Subjects from whom blood could not be drawn at visit 1.
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: aTIV
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
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one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
Otros nombres:
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Experimental: Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
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one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Periodo de tiempo: Day 22 post vaccination
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Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
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Day 22 post vaccination
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Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
Periodo de tiempo: Day 22 post vaccination
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The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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Day 22 post vaccination
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Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Periodo de tiempo: Day 22 post vaccination
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The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
Periodo de tiempo: Day 22 post vaccination
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The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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Day 22 post vaccination
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Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Periodo de tiempo: Day 22 post vaccination
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The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
Periodo de tiempo: Day 22 post vaccination
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The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
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Day 22 post vaccination
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Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
Periodo de tiempo: Day 22 post vaccination
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The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Periodo de tiempo: Day 22 post vaccination
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The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
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Day 22 post vaccination
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Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
Periodo de tiempo: Day 22 post vaccination
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The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
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Day 22 post vaccination
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Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
Periodo de tiempo: Day 22 post vaccination
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The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
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Day 22 post vaccination
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Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
Periodo de tiempo: Day 22 post vaccination
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The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Periodo de tiempo: Day 22 post vaccination
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The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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Day 22 post vaccination
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Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Periodo de tiempo: Day 22 post vaccination
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The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
Periodo de tiempo: Day 22 post vaccination
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The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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Day 22 post vaccination
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Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Periodo de tiempo: Day 22 postvaccination
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The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 postvaccination
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Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
Periodo de tiempo: Day 22 post vaccination
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The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
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Day 22 post vaccination
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Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
Periodo de tiempo: Day 22 post vaccination
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The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
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Day 22 post vaccination
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Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
Periodo de tiempo: Day 22 postvaccination
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The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 postvaccination
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Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
Periodo de tiempo: Day 22 post vaccination
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The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 22 post vaccination
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Persistence of GMTs Against Homologous and Heterologous Strains
Periodo de tiempo: Day 181, Day 366 post vaccination
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The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
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Day 181, Day 366 post vaccination
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Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
Periodo de tiempo: Day 181, Day 366 post vaccination
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The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
Day 181, Day 366 post vaccination
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Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Periodo de tiempo: Day 22 through Day 366 post vaccination
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The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
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Day 22 through Day 366 post vaccination
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Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
Periodo de tiempo: Day 1 through Day 366 post vaccination
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The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
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Day 1 through Day 366 post vaccination
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Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
Periodo de tiempo: Day 1 through Day 366 post vaccination
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The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
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Day 1 through Day 366 post vaccination
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All Cause Mortality Rate, Across Vaccine Groups
Periodo de tiempo: Day 1 through Day 366 post vaccination
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The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
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Day 1 through Day 366 post vaccination
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Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Periodo de tiempo: Day 1 through Day 7 post vaccination
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The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
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Day 1 through Day 7 post vaccination
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 agosto de 2010
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de noviembre de 2011
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2010
Publicado por primera vez (Estimar)
14 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2014
Última verificación
1 de junio de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- V70_27
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .