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Prevenar13 Post Market Surveillance

20 декабря 2016 г. обновлено: Pfizer

Post Marketing Surveillance To Observe Safety Of Prevenar 13

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

non-randomization, non-probability sampling

Тип исследования

Наблюдательный

Регистрация (Действительный)

649

Контакты и местонахождение

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

Места учебы

  • Корея, Республика
      • Busan, Корея, Республика, 602-739
        • Busan National University Hospital
      • Daegu, Корея, Республика, 701847
        • Jaeil Alliance Pediatrics Clinic
      • Daegu, Корея, Республика, 702886
        • Teun Teun Pediatric Clinic
      • Daejeon, Корея, Республика, 302-799
        • Eulji University Hospital
      • Gyeonggi-do, Корея, Республика, 425-707
        • Korea University Ansan Hospital
      • Gyeonggi-do, Корея, Республика, 463-712
        • CHA Bundang Medical Center, CHA University
      • Incheon, Корея, Республика, 400-711
        • Inha University Hospital
      • Incheon, Корея, Республика, 402-852
        • Lee Ha Young Pediatrics
      • Seoul, Корея, Республика, 138-736
        • Asan Medical Center
      • Seoul, Корея, Республика, 139-711
        • Eulji Medical Center
      • Suyeong-gu, Корея, Республика, 613-806
        • JaMo Women's Hospital
      • Ulsan, Корея, Республика, 682-714
        • Ulsan University Hospital
    • Gangwon-do
      • Wonju-si, Gangwon-do, Корея, Республика, 220-956
        • Choi's Pediatric Clinic
    • Gyeonggi-do
      • Osan, Gyeonggi-do, Корея, Республика, 447-804
        • Seoul Children's Hospital
      • Seongnam-si, Gyeonggi-do, Корея, Республика, 463-821
        • Bundang Pediatric Clinic
      • Suwon-si, Gyeonggi-do, Корея, Республика, 443-471
        • Teun Teun Pediatric Clinic
      • Yangju, Gyeonggi-do, Корея, Республика, 482-050
        • Namujungwon Women's Hospital
      • Yongin-si, Gyeonggi-do, Корея, Республика, 448-508
        • Yonsei Pediatric Clinic

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 1 месяц до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage

Описание

Inclusion Criteria:

  • Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

  • Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

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

  • Наблюдательные модели: Только для случая
  • Временные перспективы: Перспективный

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Группа 1
Биологический: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Другие имена:
  • Превенар 13

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Временное ограничение: Within 7 days after Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 1
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Временное ограничение: Within 7 days after Vaccination 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Временное ограничение: Within 7 days after Vaccination 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 3
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Временное ограничение: Within 28 days after Vaccination 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 28 days after Vaccination 4
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Временное ограничение: Within 7 days after Vaccination 1
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 1
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Временное ограничение: Within 7 days after Vaccination 2
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 2
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Временное ограничение: Within 7 days after Vaccination 3
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 3
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Временное ограничение: Within 28 days after Vaccination 4
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 28 days after Vaccination 4

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Duration of Adverse Events (AEs)
Временное ограничение: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.
Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants With Adverse Events (AEs) by Severity
Временное ограничение: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
Number of Participants With Outcome in Response to Adverse Events (AEs)
Временное ограничение: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.
Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants Discontinued Due to Adverse Events
Временное ограничение: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Baseline up to 28 days after last dose of study vaccination (13 Months)

Соавторы и исследователи

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

Спонсор

Pfizer

Публикации и полезные ссылки

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

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

1 сентября 2011 г.

Первичное завершение (Действительный)

1 января 2016 г.

Завершение исследования (Действительный)

1 января 2016 г.

Даты регистрации исследования

Первый отправленный

30 сентября 2011 г.

Впервые представлено, что соответствует критериям контроля качества

9 января 2012 г.

Первый опубликованный (Оценивать)

12 января 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 февраля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 декабря 2016 г.

Последняя проверка

1 декабря 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 6096A1-4029
  • B1851057 (Другой идентификатор: Alias Study Number)

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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