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Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

9 мая 2018 г. обновлено: GlaxoSmithKline

A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

4561

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

  • Канада
    • Nova Scotia
      • Halifax, Nova Scotia, Канада, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, Канада, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • London, Ontario, Канада, N5W 6A2
        • GSK Investigational Site
      • Sarnia, Ontario, Канада, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Канада, P3E 6C3
        • GSK Investigational Site
      • Woodstock, Ontario, Канада, N4S 4G3
        • GSK Investigational Site
    • Quebec
      • Pointe-Claire, Quebec, Канада, H9R 4S3
        • GSK Investigational Site
      • Quebec City, Quebec, Канада, G1E 7G9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Канада, J1H 4J6
        • GSK Investigational Site
      • St-Romuald, Quebec, Канада, G6W 5M6
        • GSK Investigational Site
  • Соединенные Штаты
    • Alabama
      • Huntsville, Alabama, Соединенные Штаты, 35802
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Соединенные Штаты, 85020
        • GSK Investigational Site
    • California
      • Anaheim, California, Соединенные Штаты, 92801
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32216
        • GSK Investigational Site
      • Melbourne, Florida, Соединенные Штаты, 32935
        • GSK Investigational Site
      • Miami, Florida, Соединенные Штаты, 33143
        • GSK Investigational Site
      • Pembroke Pines, Florida, Соединенные Штаты, 33024
        • GSK Investigational Site
    • Georgia
      • Stockbridge, Georgia, Соединенные Штаты, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60610
        • GSK Investigational Site
      • Peoria, Illinois, Соединенные Штаты, 61602
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, Соединенные Штаты, 46601
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, Соединенные Штаты, 66219
        • GSK Investigational Site
      • Wichita, Kansas, Соединенные Штаты, 67207
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, Соединенные Штаты, 70006
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, Соединенные Штаты, 20850
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Соединенные Штаты, 63141
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Соединенные Штаты, 59801
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Соединенные Штаты, 89104
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, Соединенные Штаты, 08817
        • GSK Investigational Site
    • New York
      • Poughkeepsie, New York, Соединенные Штаты, 12601
        • GSK Investigational Site
      • Rochester, New York, Соединенные Штаты, 14609
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Соединенные Штаты, 27612
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44122
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Соединенные Штаты, 16506
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15236
        • GSK Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Соединенные Штаты, 29303
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Соединенные Штаты, 78705
        • GSK Investigational Site
      • Fort Worth, Texas, Соединенные Штаты, 76135
        • GSK Investigational Site
      • San Angelo, Texas, Соединенные Штаты, 76904
        • GSK Investigational Site

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

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • A male or female 18 years of age or greater at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
  • Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
  • Access to a consistent means of telephone contact.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

  • Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
  • Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
  • Administration of any vaccines within 30 days before study enrollment.
  • Previous administration of any H5N1 vaccine.
  • Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
  • Lactating or nursing.
  • Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

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: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Influenza A (H5N1) 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Плацебо Компаратор: Placebo 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Placebo
Two intramuscular injections at Days 0 and 21.
Экспериментальный: Influenza A (H5N1) >64Y Group
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Плацебо Компаратор: Placebo >64Y Group
Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Placebo
Two intramuscular injections at Days 0 and 21.
Экспериментальный: Influenza A (H5N1) Group
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Плацебо Компаратор: Placebo Group
Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Placebo
Two intramuscular injections at Days 0 and 21.
Экспериментальный: Influenza A (H5N1) 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Плацебо Компаратор: Placebo 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Placebo
Two intramuscular injections at Days 0 and 21.
Экспериментальный: Influenza A (H5N1) >60Y Group
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
Плацебо Компаратор: Placebo >60Y Group
Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Биологический: Placebo
Two intramuscular injections at Days 0 and 21.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Временное ограничение: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Временное ограничение: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With Any Solicited Local Symptoms.
Временное ограничение: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Solicited General Symptoms.
Временное ограничение: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Временное ограничение: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
Number of Subjects With Serious Adverse Events (SAEs)
Временное ограничение: From Day 0 through Day 182 and through Day 379.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From Day 0 through Day 182 and through Day 379.
Number of Subjects With Medically Attended Events (MAEs)
Временное ограничение: From Day 0 through Day 182 and through Day 364.
From Day 0 through Day 182 and through Day 364.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Временное ограничение: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Временное ограничение: At Month 6 (Day 182) post Dose 1
At Month 6 (Day 182) post Dose 1
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Временное ограничение: At Month 6 (Day 182) after Dose 1
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
At Month 6 (Day 182) after Dose 1
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Временное ограничение: At Month 6 (Day 182) after Dose 1
At Month 6 (Day 182) after Dose 1
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Временное ограничение: At Month 6 (Day 182) after Dose 1
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
At Month 6 (Day 182) after Dose 1
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Временное ограничение: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Временное ограничение: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers were expressed as Geometric Mean Titers (GMTs).
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Соавторы и исследователи

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

Спонсор

GlaxoSmithKline

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

Полезные ссылки

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

23 января 2008 г.

Первичное завершение (Действительный)

15 октября 2008 г.

Завершение исследования (Действительный)

19 марта 2009 г.

Даты регистрации исследования

Первый отправленный

28 января 2008 г.

Впервые представлено, что соответствует критериям контроля качества

5 февраля 2008 г.

Первый опубликованный (Оценивать)

15 февраля 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

8 июня 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 мая 2018 г.

Последняя проверка

1 октября 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 110464

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Данные исследования/документы

  1. План статистического анализа
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  2. Отчет о клиническом исследовании
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  3. Аннотированная форма отчета о случае
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  4. Индивидуальный набор данных участников
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  5. Спецификация набора данных
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  6. Форма информированного согласия
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  7. Протокол исследования
    Информационный идентификатор: 110464
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register

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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