Prevenar (PCV-7) Post-Licensure Safety Study In Russia
26 июля 2012 г. обновлено: Pfizer
Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.
The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Действительный)
100
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Moscow, Российская Федерация, 119049
- Russian State Medical University
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Moscow, Российская Федерация, 119296
- Russian Academy of Medical Sciences
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Saint Petersburg, Российская Федерация, 197022
- Research Institute of Childhood Infections
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Yekaterinburg, Российская Федерация, 620085
- City Children's Clinical Hospital #8
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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 месяца до 1 год (Ребенок)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Infants and Children from 3 months to 23 months at enrollment
Описание
Inclusion Criteria:
- Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
- Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
- Parents or legal guardians willing and able to complete the diary cards.
Exclusion Criteria:
- Hypersensitivity to the active substances or to any of the excipients;
- Hypersensitivity to diphtheria toxoid;
- Age less than 3 months or greater than or equal to 2 years at enrollment;
- Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
- Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
- Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
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
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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healthy children after vaccination
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Non-interventional observational study
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants With Febrile Reactions Post-dose 1
Временное ограничение: Day 1 to Day 3 post-dose 1
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C).
Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
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Day 1 to Day 3 post-dose 1
|
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Percentage of Participants With Febrile Reactions Post-dose 2
Временное ограничение: Day 1 to Day 3 post-dose 2
|
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Febrile Reactions Post-dose 3
Временное ограничение: Day 1 to Day 3 post-dose 3
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
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Day 1 to Day 3 post-dose 3
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Percentage of Participants With Febrile Reactions Post-dose 4
Временное ограничение: Day 1 to Day 3 post-dose 4
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Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
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Day 1 to Day 3 post-dose 4
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Временное ограничение: Day 1 to Day 3 post-dose 1
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 1
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Временное ограничение: Day 1 to Day 3 post-dose 2
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Временное ограничение: Day 1 to Day 3 post-dose 3
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 3
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Временное ограничение: Day 1 to Day 3 post-dose 4
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 4
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Временное ограничение: Day 1 to Day 3 post-dose 1
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Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 1
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Временное ограничение: Day 1 to Day 3 post-dose 2
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Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Day 1 to Day 3 post-dose 2
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Временное ограничение: Day 1 to Day 3 post-dose 3
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 3
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|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Временное ограничение: Day 1 to Day 3 post-dose 4
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 4
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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 декабря 2009 г.
Первичное завершение (Действительный)
1 августа 2011 г.
Завершение исследования (Действительный)
1 августа 2011 г.
Даты регистрации исследования
Первый отправленный
21 сентября 2010 г.
Впервые представлено, что соответствует критериям контроля качества
21 сентября 2010 г.
Первый опубликованный (Оценивать)
23 сентября 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
31 августа 2012 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 июля 2012 г.
Последняя проверка
1 июля 2012 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 0887X1-4596
- B1841011
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. .