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Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

2 июля 2018 г. обновлено: GlaxoSmithKline

Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of:

0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed.

The children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6.

Two blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control.

The parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.

Тип исследования

Интервенционный

Регистрация (Действительный)

390

Фаза

  • Фаза 2

Контакты и местонахождение

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

Места учебы

  • Канада
    • Alberta
      • Calgary, Alberta, Канада, T3B 6A8
        • GSK Investigational Site
    • British Columbia
      • Langley, British Columbia, Канада, V3A 4H9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3E 3P4
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Канада, A1N 5B6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Канада, B3K 6R8
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Канада, L8L 5G8
        • GSK Investigational Site
      • London, Ontario, Канада, N6H 4P2
        • GSK Investigational Site
      • London, Ontario, Канада, N6A 5R9
        • GSK Investigational Site
      • Mississauga, Ontario, Канада, L5A 3V4
        • GSK Investigational Site
      • Newmarket, Ontario, Канада, L3Y 5G8
        • GSK Investigational Site
      • Sarnia, Ontario, Канада, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Канада, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Канада, M5G 1N8
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Канада, C1A 5N4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Канада, H3T 1C5
        • GSK Investigational Site
      • Quebec City, Quebec, Канада, G1V 4M6
        • GSK Investigational Site
      • Ste-Foy, Quebec, Канада, G1X 3V7
        • GSK Investigational Site
      • Trois Rivières, Quebec, Канада, G8T 7A1
        • 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 6 месяцев до 3 года (Ребенок)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
  • Subjects must be in good health established by medical history and physical examination before entering into the study;
  • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
  • Written informed consent obtained from the subject's parent/guardian.
  • Parents/guardian access to a consistent means of telephone contact, land line or mobile

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;
  • History of hypersensitivity to any vaccine;
  • History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
  • History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
  • Acute disease at the time of enrolment.
  • History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
  • Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
  • Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
  • Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
  • Any use of analgesics/antipyretics 12 hours before receipt of vaccine.

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: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Fluviral F1 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Биологический: GSK Biologicals' influenza vaccine GSK1557482A
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Другие имена:
  • Речной
Экспериментальный: Fluviral F2 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Биологический: GSK Biologicals' influenza vaccine GSK1557482A
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Другие имена:
  • Речной
Активный компаратор: Vaxigrip Group
Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Биологический: Vaxigrip
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Временное ограничение: During the 4-day follow-up period (Days 0-3) after any vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Временное ограничение: During the 4-day follow-up period (Days 0-3) after any vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Временное ограничение: During the 28-day follow-up period (Days 0-27) after vaccination
Unsolicited AEs covers any AE 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day follow-up period (Days 0-27) after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Временное ограничение: During the 28-day post-vaccination period

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Временное ограничение: During the 6-month safety follow up after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 6-month safety follow up after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Временное ограничение: During the 28-day post-vaccination period

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Временное ограничение: During the 6-month safety follow up after vaccination

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 6-month safety follow up after vaccination

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Временное ограничение: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of Subjects Seroconverted to HI Antibodies
Временное ограничение: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Number of Subjects Seroprotected Against HI Antibodies
Временное ограничение: At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Seroconversion Factor for HI Antibodies
Временное ограничение: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Временное ограничение: During the 4-day follow-up period (Days 0-3) after any vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Временное ограничение: During the 4-day follow-up period (Days 0-3) after any vaccination

Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Временное ограничение: During the 28-day follow-up period (Days 0-27) after vaccination

Unsolicited AEs covers any AE 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day follow-up period (Days 0-27) after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Временное ограничение: During the 28-day post-vaccination period after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day post-vaccination period after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Временное ограничение: During the 6-month safety follow up after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 6-month safety follow up after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Временное ограничение: During the 28-day post-vaccination period

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Временное ограничение: During the 6-month safety follow up after vaccination

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 6-month safety follow up after vaccination

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

10 ноября 2008 г.

Первичное завершение (Действительный)

19 августа 2009 г.

Завершение исследования (Действительный)

19 августа 2009 г.

Даты регистрации исследования

Первый отправленный

23 октября 2008 г.

Впервые представлено, что соответствует критериям контроля качества

23 октября 2008 г.

Первый опубликованный (Оценивать)

24 октября 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 августа 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июля 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

  • 111635

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. Отчет о клиническом исследовании
    Информационный идентификатор: 111635
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  2. Спецификация набора данных
    Информационный идентификатор: 111635
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  3. План статистического анализа
    Информационный идентификатор: 111635
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  4. Форма информированного согласия
    Информационный идентификатор: 111635
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  5. Индивидуальный набор данных участников
    Информационный идентификатор: 111635
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  6. Протокол исследования
    Информационный идентификатор: 111635
    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

Клинические исследования GSK Biologicals' influenza vaccine GSK1557482A

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