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

16 juni 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

7109

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Filippinerna
      • Pasay City, Filippinerna, 1300
        • 110, San Juan de Dios Hospital, 2772 Roxas Blvd
      • Quezon City, Filippinerna, 1102
        • 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
    • Cavite
      • DBB B Dasmarinas, Cavite, Filippinerna, 4114
        • 103, De La Salle Health Sciences Institute
      • Dbbb Dasmarinas, Cavite, Filippinerna, 4114
        • 102, De La Salle Health Sciences Institute
    • Manila
      • Ermita, Manila, Filippinerna, 1000
        • 105, Manila Doctors Hospital, 667 United Nations Avenue
      • Mesa, Manila, Filippinerna, 1016
        • 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
      • Rizal Avenue Avenida Cruz, Manila, Filippinerna, 1003
        • 104 Jose Reyes Memorial Medical Center
      • Taft Avenue, Manila, Filippinerna, 1000
        • 107 Philippine General Hospital
    • Muntinlupa
      • Corporate City Alabang, Muntinlupa, Filippinerna, 1781
        • 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
      • Corporate City Alabang, Muntinlupa, Filippinerna
        • 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
    • Rosa City
      • City Health Office 1, Rosa City, Filippinerna, 4026
        • 108, City Health Office 1 Rosa City
  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85253
        • 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
    • Florida
      • Deland, Florida, Förenta staterna, 32720
        • 318 Avail Clinical Research, 860 Peachwood Drive
      • Jacksonville, Florida, Förenta staterna, 32205
        • 306 Westside Center for Clinical Research, 810 Lane Avenue South
      • Miami, Florida, Förenta staterna, 33143
        • 328 Miami Research Associates, 6141 Sunset Drive
    • Kansas
      • Lenexa, Kansas, Förenta staterna, 66219
        • 320 Johnson County Clin-Trials, 15602 College Blvd
      • Newton, Kansas, Förenta staterna, 67114
        • 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
      • Wichita, Kansas, Förenta staterna, 67205
        • 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
      • Wichita, Kansas, Förenta staterna, 67207
        • 322 Heartland Research Associates Wichita, 1709 S. Rock Road
    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63104
        • 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
      • Saint Louis, Missouri, Förenta staterna, 63141
        • 330 Mercy Health Research, 12680 Olive Blvd Suite 200
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89130
        • 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
    • New York
      • Endwell, New York, Förenta staterna, 13760
        • 311 Regional Clinical Research INC, 415 Hooper Road
    • North Carolina
      • Raleigh, North Carolina, Förenta staterna, 27612
        • 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
    • Ohio
      • Franklin, Ohio, Förenta staterna, 45005
        • 303 Prestige Clinical Research, 333 Conover Drive
    • Rhode Island
      • Warwick, Rhode Island, Förenta staterna, 02886
        • 325 Omega Medical Research, 400 Bald Hill Road
    • South Carolina
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • 312 Spartanburg Regional Medical Center, 485 Simuel Road
    • Utah
      • Jordan, Utah, Förenta staterna
        • 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
      • Salt Lake City, Utah, Förenta staterna, 84109
        • 317 J. Lewis Research Inc., 2295 Foothill Drive
      • Salt Lake City, Utah, Förenta staterna, 84121
        • 305 Foothill Family Clinic South, 6360 South 3000 East
    • Virginia
      • Fairfax, Virginia, Förenta staterna, 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • Fluad
Experimentell: 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
Andra namn:
  • Agriflu

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Vaccines

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 november 2011

Studieregistreringsdatum

Först inskickad

13 juli 2010

Först inskickad som uppfyllde QC-kriterierna

13 juli 2010

Första postat (Uppskatta)

14 juli 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • V70_27

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