Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
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
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85253
- 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
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Florida
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Deland、Florida、アメリカ、32720
- 318 Avail Clinical Research, 860 Peachwood Drive
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Jacksonville、Florida、アメリカ、32205
- 306 Westside Center for Clinical Research, 810 Lane Avenue South
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Miami、Florida、アメリカ、33143
- 328 Miami Research Associates, 6141 Sunset Drive
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Kansas
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Lenexa、Kansas、アメリカ、66219
- 320 Johnson County Clin-Trials, 15602 College Blvd
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Newton、Kansas、アメリカ、67114
- 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
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Wichita、Kansas、アメリカ、67205
- 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
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Wichita、Kansas、アメリカ、67207
- 322 Heartland Research Associates Wichita, 1709 S. Rock Road
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Missouri
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Saint Louis、Missouri、アメリカ、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、アメリカ、63141
- 330 Mercy Health Research, 12680 Olive Blvd Suite 200
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Nevada
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Las Vegas、Nevada、アメリカ、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、アメリカ、13760
- 311 Regional Clinical Research INC, 415 Hooper Road
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North Carolina
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Raleigh、North Carolina、アメリカ、27612
- 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
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Winston-Salem、North Carolina、アメリカ、27103
- 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
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Ohio
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Franklin、Ohio、アメリカ、45005
- 303 Prestige Clinical Research, 333 Conover Drive
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Rhode Island
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Warwick、Rhode Island、アメリカ、02886
- 325 Omega Medical Research, 400 Bald Hill Road
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South Carolina
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Spartanburg、South Carolina、アメリカ、29303
- 312 Spartanburg Regional Medical Center, 485 Simuel Road
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Utah
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Jordan、Utah、アメリカ
- 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
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Salt Lake City、Utah、アメリカ、84109
- 317 J. Lewis Research Inc., 2295 Foothill Drive
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Salt Lake City、Utah、アメリカ、84121
- 305 Foothill Family Clinic South, 6360 South 3000 East
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Virginia
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Fairfax、Virginia、アメリカ、22030
- 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
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Bogota
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Avenida Carrera 68、Bogota、コロンビア
- 209, Centro de Investigacion CAFAM
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Carrera 42A、Bogota、コロンビア、1750
- 206, Centro de Atencion e Investigacion Medica CAIMED
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Carrera 42A、Bogota、コロンビア、1750
- 213, Centro de Atencion e Investigacion Medica CAIMED
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Cra 14 No Piso Sexto、Bogota、コロンビア
- 207, Centro de Investigacion Cafesalud Medicina Prepagada
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Clayton ciudad del Saber Edificio 118、パナマ
- 203, Health Research International HRI
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Consultorios Royal Center 108、パナマ
- 205, Medical and Research Center Calle 53 Urbanizacion Marbella
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Pasay City、フィリピン、1300
- 110, San Juan de Dios Hospital, 2772 Roxas Blvd
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Quezon City、フィリピン、1102
- 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
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Cavite
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DBB B Dasmarinas、Cavite、フィリピン、4114
- 103, De La Salle Health Sciences Institute
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Dbbb Dasmarinas、Cavite、フィリピン、4114
- 102, De La Salle Health Sciences Institute
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Manila
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Ermita、Manila、フィリピン、1000
- 105, Manila Doctors Hospital, 667 United Nations Avenue
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Mesa、Manila、フィリピン、1016
- 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
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Rizal Avenue Avenida Cruz、Manila、フィリピン、1003
- 104 Jose Reyes Memorial Medical Center
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Taft Avenue、Manila、フィリピン、1000
- 107 Philippine General Hospital
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Muntinlupa
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Corporate City Alabang、Muntinlupa、フィリピン、1781
- 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
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Corporate City Alabang、Muntinlupa、フィリピン
- 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、フィリピン、4026
- 108, City Health Office 1 Rosa City
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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
他の名前：
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実験的：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- V70_27
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。