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

16 июня 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

7109

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

65 лет и старше (Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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).
Биологический: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
Другие имена:
  • Флюад
Экспериментальный: Licensed TIV
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Биологический: Non-adjuvanted trivalent subunit influenza vaccine (TIV)
one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
Другие имена:
  • Агрифлю

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novartis Vaccines

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2010 г.

Первичное завершение (Действительный)

1 августа 2011 г.

Завершение исследования (Действительный)

1 ноября 2011 г.

Даты регистрации исследования

Первый отправленный

13 июля 2010 г.

Впервые представлено, что соответствует критериям контроля качества

13 июля 2010 г.

Первый опубликованный (Оценивать)

14 июля 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

26 июня 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 июня 2014 г.

Последняя проверка

1 июня 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • V70_27

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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