Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
16 de junho de 2014 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
7109
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
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Bogota
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Avenida Carrera 68, Bogota, Colômbia
- 209, Centro de Investigacion CAFAM
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Carrera 42A, Bogota, Colômbia, 1750
- 206, Centro de Atencion e Investigacion Medica CAIMED
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Carrera 42A, Bogota, Colômbia, 1750
- 213, Centro de Atencion e Investigacion Medica CAIMED
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Cra 14 No Piso Sexto, Bogota, Colômbia
- 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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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
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
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: 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
Outros nomes:
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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
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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Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
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
1 de agosto de 2010
Conclusão Primária (Real)
1 de agosto de 2011
Conclusão do estudo (Real)
1 de novembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de julho de 2010
Primeira postagem (Estimativa)
14 de julho de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de junho de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de junho de 2014
Última verificação
1 de junho de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V70_27
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 .