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Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

20 октября 2015 г. обновлено: Novartis

A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

3604

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

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

Места учебы

  • Венгрия
      • Budapest, Венгрия, 1042
        • Site 57: Házi Gyermekorvosi Rendelő
      • Budapest, Венгрия, 1089
        • Site 53: Heim Pál Gyermekkórház
      • Budapest, Венгрия, 1097
        • Site 52: Ferencvárosi Gyermekorvos Kft.
      • Budapest, Венгрия, 1136
        • Site 56: Házi Gyermekorvosi Rendelő
      • Budapest, Венгрия, 1173
        • Site 54: Házi Gyermekorvosi Rendelő
      • Miskolc, Венгрия, 3534
        • Site 51: 5053. számú Gyermekorvosi Rendelő
      • Nyíregyháza, Венгрия, 4481
        • Site 55: Revamed kft.
      • Szombathely, Венгрия, 9700
        • Site 59: Vas Megyei Markusovszky Lajos, Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház
  • Италия
      • Ferrara, Италия, 44100
        • Site 42: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva
      • Genova, Италия, 16132
        • Site 47: Dipartimento Scienze della Salute, Sezione di Igiene e Medicina Preventiva, Univesità di Genova
      • Novara, Италия, 28100
        • Site 41: Ospedale Maggiore della Carità-Clinica Pediatrica
      • Perugia, Италия, 06070
        • Site 46: USL 2 Perugia, Distretto del perugino, Centro di Salute n. 4 (Madonna Alta) e n. 6 (Ellera di Corciano del distretto del perugino)
      • Ragusa, Италия, 97100
        • Site 45: AUSL 7
  • Литва
      • Kaunas, Литва, 48259
        • Site 35
      • Vilnius, Литва, 01117
        • Site 36
      • Vilnius, Литва, 02169
        • Site 32
      • Vilnius, Литва, 04318
        • Site 34
      • Vilnius, Литва, 10207
        • Site 31
      • Vilnius, Литва, 11200
        • Site 33
  • Румыния
    • Arges
      • Campulung Muscel, Arges, Румыния, 115100
        • Site 25
    • Dolj
      • Craiova, Dolj, Румыния, 200642
        • Site 21
  • Соединенные Штаты
    • Arkansas
      • Fayetteville, Arkansas, Соединенные Штаты, 72703
        • Site 09
    • California
      • Downey, California, Соединенные Штаты, 90241
        • Site 10
    • Kentucky
      • Bardstown, Kentucky, Соединенные Штаты, 40004
        • Site 02
    • Louisiana
      • Metairie, Louisiana, Соединенные Штаты, 70006
        • Site 14
    • Missouri
      • St. Louis, Missouri, Соединенные Штаты, 63104
        • Site 01
    • Nebraska
      • Omaha, Nebraska, Соединенные Штаты, 68134
        • Site 11
    • New Jersey
      • Edison, New Jersey, Соединенные Штаты, 08817
        • Site 04
    • New York
      • Endwell, New York, Соединенные Штаты, 13760
        • Site 05
    • Texas
      • Fort Worth, Texas, Соединенные Штаты, 76135
        • Site 16
      • San Angelo, Texas, Соединенные Штаты, 76904
        • Site 13
      • San Antonio, Texas, Соединенные Штаты, 78205
        • Site 12
    • Utah
      • Bountiful, Utah, Соединенные Штаты, 84010
        • Site 08
      • Salt Lake City, Utah, Соединенные Штаты, 84109
        • Site 07
      • Salt Lake City, Utah, Соединенные Штаты, 84121
        • Site 03
    • Virginia
      • Burke, Virginia, Соединенные Штаты, 22105
        • Site 06
    • Washington
      • Spokane, Washington, Соединенные Штаты, 99202
        • Site 15
  • Финляндия
      • Helsinki, Финляндия, 00100
        • Site 71: Etelä-Helsingin rokotetutkimusklinikka
      • Helsinki, Финляндия, 00930
        • Site 72: Itä-Helsingin rokotetutkimusklinikka
      • Järvenpää, Финляндия, 04400
        • Site 76: Järvenpään rokotetutkimusklinikka
      • Kotka, Финляндия, 48600
        • Site 77: Kotkan rokotetutkimusklinikka
      • Lahti, Финляндия, 15140
        • Site 67: Lahden rokotetutkimusklinikka
      • Oulu, Финляндия, 90100
        • Site 75: Oulun rokotetutkimusklinikka
      • Pori, Финляндия, 28120
        • Site 68: Porin rokotetutkimusklinikka
      • Tampere, Финляндия, 33100
        • Site 66: Tampereen rokotetutkimusklinikka
      • Turku, Финляндия, 20520
        • Site 69: Turun rokotetutkimusklinikka
      • Vantaa, Финляндия, 01300
        • Site 73: Itä-Vantaan rokotetutkimusklinikka
      • Vantaa, Финляндия, 01600
        • Site 74: Länsi-Vantaan rokotetutkimusklinikka
    • Espoo
      • Heikintori, Espoo, Финляндия, 02100
        • Site 70: Espoon rokotetutkimusklinikka
    • Kokkola
      • Rantakatu 7, Kokkola, Финляндия, 67100
        • Site 79: Kokkola Vaccine Research Clinic
    • Kuopio
      • Microkatu 1,Osa/Section A, 3rd floor PL1188, Kuopio, Финляндия, 70211
        • Site 78: Kuopio Vaccine Research Clinic
  • Хорватия
      • Dakovo, Хорватия
        • Site 44:Spec. Pediatric Dispensary
      • Ljudevita Gaja 2, Djakovo, Хорватия
        • Site 83
      • Sisak, Хорватия
        • Site 43: Spec. Pediatric Dispensary
      • Zagreb, Хорватия
        • Site 27:Institute of Public Health
      • Zagreb, Хорватия
        • Site 29: Institute of Public Health
      • Zagreb, Хорватия
        • Site 40:Spec. Pediatric Dispensary
      • Zagreb, Хорватия
        • Site 49: Spec. Pediatric Dispensary
      • Zagreb, Хорватия
        • Site 50: Spec. Pediatric Dispensary
      • Zagreb, Хорватия
        • Site 86: Spec. Pediatric Dispensary

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

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs;

  2. In good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator;
  3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

Exclusion Criteria:

  1. Any serious disease, such as:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. diabetes mellitus,
    4. chronic pulmonary disease,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease;
  2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;

  3. Known or suspected impairment/alteration of immune function, including:

    1. use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1,
    2. cancer chemotherapy,
    3. receipt of immunostimulants within 60 days prior to Visit 1,
    4. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
    5. known HIV infection or HIV-related disease;
  4. History of Guillain-Barré syndrome;
  5. Bleeding diathesis;
  6. Surgery planned during the study period;
  7. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
  8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
  9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season;
  11. Receipt of an influenza vaccine within 6 months prior to Visit 1;
  12. Experienced a temperature 38.0°C [100.4°F]) and/or any acute illness within 3 days prior to Visit 1;
  13. Pregnant or nursing mother;
  14. Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control;
  15. Children of research staff or those living with research staff directly involved with the clinical study. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
  16. Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV
All subjects received one 0.5 mL IM injection, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Биологический: Cell culture-derived influenza subunit vaccine (cTIV)
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Биологический: Cell culture-derived influenza subunit vaccine (cTIV)
Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
Активный компаратор: Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV
All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere.
Биологический: Egg derived influenza subunit vaccine (eTIV)
One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Биологический: Egg derived influenza subunit vaccine (eTIV)
Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
Экспериментальный: Cohort 3 (3-8 Yrs) cTIV
All subjects received two 0.5 mL injections, administered four weeks apart, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Биологический: Cell culture-derived influenza subunit vaccine (cTIV)
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Биологический: Cell culture-derived influenza subunit vaccine (cTIV)
Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
Активный компаратор: Cohort 3 (3-8 Yrs) eTIV
All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Биологический: Egg derived influenza subunit vaccine (eTIV)
One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Биологический: Egg derived influenza subunit vaccine (eTIV)
Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 50 post vaccination

To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.

GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 50 post vaccination

To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.

Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Временное ограничение: Day 29 post vaccination

To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.

GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 29 post vaccination
Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Временное ограничение: Day 29 post vaccination

Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.

The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5.
Day 29 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Временное ограничение: Day 29 post vaccination

To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.

This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Временное ограничение: Day 29 post vaccination

Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.

According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 post vaccination
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 29 and Day 50 post vaccination
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.
Day 29 and Day 50 post vaccination
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 29 and Day 50 post vaccination

To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.

The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 29 and Day 50 post vaccination

To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.

The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
Временное ограничение: Day 29 and Day 50 post vaccination

Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.

According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 and Day 50 post vaccination
Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Временное ограничение: up to 7 days after vaccination
To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .
up to 7 days after vaccination
Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
Временное ограничение: up to 7 days after each vaccination
To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.
up to 7 days after each vaccination

Соавторы и исследователи

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

Спонсор

Novartis

Соавторы

Novartis Vaccines

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

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 октября 2007 г.

Первичное завершение (Действительный)

1 февраля 2008 г.

Завершение исследования (Действительный)

1 июля 2008 г.

Даты регистрации исследования

Первый отправленный

21 марта 2008 г.

Впервые представлено, что соответствует критериям контроля качества

21 марта 2008 г.

Первый опубликованный (Оценивать)

27 марта 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

23 ноября 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 октября 2015 г.

Последняя проверка

1 октября 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • V58P12
  • Eudract Number: 2007-001534-13

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

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