A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
9 августа 2018 г. обновлено: GlaxoSmithKline
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
119
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
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Sachsen
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Dresden, Sachsen, Германия, 01309
- GSK Investigational Site
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Dresden, Sachsen, Германия, 01097
- GSK Investigational Site
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Dresden, Sachsen, Германия, 01099
- GSK Investigational Site
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Dresden, Sachsen, Германия, 01129
- GSK Investigational Site
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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
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- Administration of an influenza vaccine within the six months preceding the study vaccination.
- Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- Acute disease and/or fever at the time of enrolment.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic underlying disease, not stabilized or clinically serious.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of Guillain-Barré syndrome.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Anaphylaxis following the administration of vaccine(s).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
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: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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Экспериментальный: Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Временное ограничение: At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
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At Day 0 and Day 21
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Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 0 and Day 21
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Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
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At Day 0 and Day 21
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Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 21
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A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
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At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 21
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MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.
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At Day 21
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Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
Временное ограничение: At Day 21
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SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
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At Day 21
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 0 and Day 21
|
Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains included H1N1, H3N2 and Yamagata antigens.
The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.
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At Day 0 and Day 21
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Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 0 and Day 21
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Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
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At Day 0 and Day 21
|
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Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 21
|
SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
|
At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Временное ограничение: At Day 21
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MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.
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At Day 21
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Duration of Solicited Local Symptoms.
Временное ограничение: During the 4-day follow-up period (Days 0-3) after vaccination
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Duration was defined as number of days with any grade of local symptoms.
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During the 4-day follow-up period (Days 0-3) after vaccination
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Временное ограничение: During the 4-day (Day 0-Day 3) follow-up period after vaccination
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Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling.
Any was defined as any solicited local symptom reported irrespective of intensity.
Grade 3 pain was defined as pain that prevented normal everyday activities.
Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
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During the 4-day (Day 0-Day 3) follow-up period after vaccination
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Duration of Solicited General Symptoms.
Временное ограничение: During the 4-day follow-up period (Days 0-3) after vaccination
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Duration was defined as number of days with any grade of general symptoms.
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During the 4-day follow-up period (Days 0-3) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Временное ограничение: During the 4-day follow-up period (Day 0-3) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C |
During the 4-day follow-up period (Day 0-3) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Временное ограничение: During the 21-day follow-up period (Days 0-20) after vaccination
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Unsolicited AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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During the 21-day follow-up period (Days 0-20) after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Временное ограничение: During the entire study period (Days 0-21)
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A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (Days 0-21)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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 июля 2012 г.
Первичное завершение (Действительный)
31 июля 2012 г.
Завершение исследования (Действительный)
31 июля 2012 г.
Даты регистрации исследования
Первый отправленный
24 мая 2012 г.
Впервые представлено, что соответствует критериям контроля качества
24 мая 2012 г.
Первый опубликованный (Оценивать)
28 мая 2012 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
7 сентября 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 августа 2018 г.
Последняя проверка
1 ноября 2013 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 116663
- 2012-000789-39 (Номер EudraCT)
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. .