Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

22 августа 2018 г. обновлено: GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

2116

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

  • Соединенные Штаты
    • Alabama
      • Birmingham, Alabama, Соединенные Штаты, 35205
        • GSK Investigational Site
    • Arkansas
      • Benton, Arkansas, Соединенные Штаты, 72015
        • GSK Investigational Site
    • California
      • Huntington Beach, California, Соединенные Штаты, 92647
        • GSK Investigational Site
      • Paramount, California, Соединенные Штаты, 90723
        • GSK Investigational Site
      • West Covina, California, Соединенные Штаты, 91790
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, Соединенные Штаты, 30062
        • GSK Investigational Site
      • Woodstock, Georgia, Соединенные Штаты, 30189
        • GSK Investigational Site
    • Illinois
      • DeKalb, Illinois, Соединенные Штаты, 60115
        • GSK Investigational Site
    • Kansas
      • Newton, Kansas, Соединенные Штаты, 67114
        • GSK Investigational Site
      • Wichita, Kansas, Соединенные Штаты, 67207
        • GSK Investigational Site
    • Massachusetts
      • Woburn, Massachusetts, Соединенные Штаты, 01801
        • GSK Investigational Site
    • Michigan
      • Stevensville, Michigan, Соединенные Штаты, 49127
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Соединенные Штаты, 63141
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Соединенные Штаты, 89015
        • GSK Investigational Site
    • New York
      • Cortland, New York, Соединенные Штаты, 13045
        • GSK Investigational Site
      • Syracuse, New York, Соединенные Штаты, 13210
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, Соединенные Штаты, 27518
        • GSK Investigational Site
      • Raleigh, North Carolina, Соединенные Штаты, 27609
        • GSK Investigational Site
    • Ohio
      • Austintown, Ohio, Соединенные Штаты, 44515
        • GSK Investigational Site
    • Oregon
      • Albany, Oregon, Соединенные Штаты, 97322
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Соединенные Штаты, 16505
        • GSK Investigational Site
      • Hermitage, Pennsylvania, Соединенные Штаты, 16148
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты, 29406
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Соединенные Штаты, 78705
        • GSK Investigational Site
      • Houston, Texas, Соединенные Штаты, 77055
        • GSK Investigational Site
    • Utah
      • Orem, Utah, Соединенные Штаты, 84057
        • GSK Investigational Site
      • Provo, Utah, Соединенные Штаты, 84604
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Соединенные Штаты, 22015
        • 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

От 3 года до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
  • A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
  • Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
  • Child in care
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of hypersensitivity to any vaccine.
  • History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Биологический: GSK investigational vaccine GSK1557482A
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Активный компаратор: Fluzone Group

subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
Биологический: Fluzone®
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
Временное ограничение: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
Временное ограничение: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Day 28 after last vaccine dose.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
Временное ограничение: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Временное ограничение: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
Временное ограничение: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Временное ограничение: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
Временное ограничение: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
At Day 0 and at Day 28 after last vaccine dose
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
Временное ограничение: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and at Day 28 after last vaccine dose
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Временное ограничение: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.

Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causally related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Временное ограничение: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causaly related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Временное ограничение: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Временное ограничение: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Временное ограничение: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Временное ограничение: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
Временное ограничение: During the entire study period (From Day 0 up to Day 180).
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
During the entire study period (From Day 0 up to Day 180).
Number of Subjects Reporting Serious Adverse Events (SAEs).
Временное ограничение: During the entire study period (From Day 0 up to Day 180).
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
During the entire study period (From Day 0 up to Day 180).

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

13 октября 2009 г.

Первичное завершение (Действительный)

2 марта 2010 г.

Завершение исследования (Действительный)

17 июня 2010 г.

Даты регистрации исследования

Первый отправленный

17 сентября 2009 г.

Впервые представлено, что соответствует критериям контроля качества

17 сентября 2009 г.

Первый опубликованный (Оценивать)

18 сентября 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 сентября 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 августа 2018 г.

Последняя проверка

1 сентября 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 112999

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. Протокол исследования
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  2. Спецификация набора данных
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  3. Отчет о клиническом исследовании
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  4. Индивидуальный набор данных участников
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  5. Форма информированного согласия
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  6. План статистического анализа
    Информационный идентификатор: 112999
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  7. Аннотированная форма отчета о случае
    Информационный идентификатор: 112999
    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. .

Клинические исследования Грипп

  • QIAGEN Gaithersburg, Inc
    Завершенный
    Сбор и тестирование респираторных образцов
    Респираторно-синцитиальные вирусные инфекции | Грипп А | Риновирус | Грипп В | Расширенная панель QIAGEN ResPlex II | Инфекция, вызванная вирусом парагриппа человека 1 | Парагрипп Тип 2 | Парагрипп 3 типа | Парагрипп 4 типа | Метапневмовирус человека A/B | Вирус Коксаки/Эховирус | Аденовирусы типов B/C/E | Подтипы... и другие заболевания
    Соединенные Штаты

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in Japan

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться