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Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

16. juni 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

7109

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Colombia
    • Bogota
      • Avenida Carrera 68, Bogota, Colombia
        • 209, Centro de Investigacion CAFAM
      • Carrera 42A, Bogota, Colombia, 1750
        • 206, Centro de Atencion e Investigacion Medica CAIMED
      • Carrera 42A, Bogota, Colombia, 1750
        • 213, Centro de Atencion e Investigacion Medica CAIMED
      • Cra 14 No Piso Sexto, Bogota, Colombia
        • 207, Centro de Investigacion Cafesalud Medicina Prepagada
  • Filippinerne
      • Pasay City, Filippinerne, 1300
        • 110, San Juan de Dios Hospital, 2772 Roxas Blvd
      • Quezon City, Filippinerne, 1102
        • 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
    • Cavite
      • DBB B Dasmarinas, Cavite, Filippinerne, 4114
        • 103, De La Salle Health Sciences Institute
      • Dbbb Dasmarinas, Cavite, Filippinerne, 4114
        • 102, De La Salle Health Sciences Institute
    • Manila
      • Ermita, Manila, Filippinerne, 1000
        • 105, Manila Doctors Hospital, 667 United Nations Avenue
      • Mesa, Manila, Filippinerne, 1016
        • 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
      • Rizal Avenue Avenida Cruz, Manila, Filippinerne, 1003
        • 104 Jose Reyes Memorial Medical Center
      • Taft Avenue, Manila, Filippinerne, 1000
        • 107 Philippine General Hospital
    • Muntinlupa
      • Corporate City Alabang, Muntinlupa, Filippinerne, 1781
        • 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
      • Corporate City Alabang, Muntinlupa, Filippinerne
        • 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
    • Rosa City
      • City Health Office 1, Rosa City, Filippinerne, 4026
        • 108, City Health Office 1 Rosa City
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85253
        • 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
    • Florida
      • Deland, Florida, Forenede Stater, 32720
        • 318 Avail Clinical Research, 860 Peachwood Drive
      • Jacksonville, Florida, Forenede Stater, 32205
        • 306 Westside Center for Clinical Research, 810 Lane Avenue South
      • Miami, Florida, Forenede Stater, 33143
        • 328 Miami Research Associates, 6141 Sunset Drive
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • 320 Johnson County Clin-Trials, 15602 College Blvd
      • Newton, Kansas, Forenede Stater, 67114
        • 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
      • Wichita, Kansas, Forenede Stater, 67205
        • 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
      • Wichita, Kansas, Forenede Stater, 67207
        • 322 Heartland Research Associates Wichita, 1709 S. Rock Road
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63104
        • 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
      • Saint Louis, Missouri, Forenede Stater, 63141
        • 330 Mercy Health Research, 12680 Olive Blvd Suite 200
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89130
        • 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
    • New York
      • Endwell, New York, Forenede Stater, 13760
        • 311 Regional Clinical Research INC, 415 Hooper Road
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
    • Ohio
      • Franklin, Ohio, Forenede Stater, 45005
        • 303 Prestige Clinical Research, 333 Conover Drive
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • 325 Omega Medical Research, 400 Bald Hill Road
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • 312 Spartanburg Regional Medical Center, 485 Simuel Road
    • Utah
      • Jordan, Utah, Forenede Stater
        • 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
      • Salt Lake City, Utah, Forenede Stater, 84109
        • 317 J. Lewis Research Inc., 2295 Foothill Drive
      • Salt Lake City, Utah, Forenede Stater, 84121
        • 305 Foothill Family Clinic South, 6360 South 3000 East
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22030
        • 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
  • Panama
      • Clayton ciudad del Saber Edificio 118, Panama
        • 203, Health Research International HRI
      • Consultorios Royal Center 108, Panama
        • 205, Medical and Research Center Calle 53 Urbanizacion Marbella

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

  1. 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.
  2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
  3. Known or suspected impairment/alteration of immune function.
  4. Individuals with a known bleeding diathesis.
  5. History of Guillain-Barré syndrome.
  6. 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).
  7. 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.
  8. 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.
  9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
  10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
  11. Individuals with history of substance or alcohol abuse within the past 2 years.
  12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
  13. 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.
  14. Subjects from whom blood could not be drawn at visit 1.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Biologisk: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
Andre navne:
  • Fluad
Eksperimentel: Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Biologisk: Non-adjuvanted trivalent subunit influenza vaccine (TIV)
one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
Andre navne:
  • Agriflu

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Tidsramme: Day 22 post vaccination

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
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Tidsramme: Day 22 post vaccination

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
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
Tidsramme: Day 22 post vaccination

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
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
Tidsramme: Day 22 post vaccination

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
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
Tidsramme: Day 22 post vaccination

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
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
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
Tidsramme: Day 22 postvaccination

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
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
Tidsramme: Day 22 post vaccination
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 .
Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
Tidsramme: Day 22 post vaccination
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.
Day 22 post vaccination
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
Tidsramme: Day 22 postvaccination

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
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
Tidsramme: Day 22 post vaccination

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
Persistence of GMTs Against Homologous and Heterologous Strains
Tidsramme: Day 181, Day 366 post vaccination
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.
Day 181, Day 366 post vaccination
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
Tidsramme: Day 181, Day 366 post vaccination

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
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Tidsramme: Day 22 through Day 366 post vaccination
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.
Day 22 through Day 366 post vaccination
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
Tidsramme: Day 1 through Day 366 post vaccination
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.
Day 1 through Day 366 post vaccination
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
Tidsramme: Day 1 through Day 366 post vaccination
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.
Day 1 through Day 366 post vaccination
All Cause Mortality Rate, Across Vaccine Groups
Tidsramme: Day 1 through Day 366 post vaccination
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Day 1 through Day 366 post vaccination
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Tidsramme: Day 1 through Day 7 post vaccination
The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
Day 1 through Day 7 post vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Vaccines

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

13. juli 2010

Først indsendt, der opfyldte QC-kriterier

13. juli 2010

Først opslået (Skøn)

14. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V70_27

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Influenza

Kliniske forsøg med MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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