A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
12 июля 2018 г. обновлено: Merck Sharp & Dohme LLC
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age.
From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
Обзор исследования
Статус
Завершенный
Тип исследования
Интервенционный
Регистрация (Действительный)
1518
Фаза
- Фаза 3
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 9 лет до 26 лет (Ребенок, Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
Exclusion Criteria:
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
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: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Girls 9 to 14 Years V503 at Months 0 and 6
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Экспериментальный: Boys 9 to 14 Years V503 at Months 0 and 6
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Экспериментальный: Girls and Boys 9 to 14 Years V503 at Months 0 and 12
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Экспериментальный: Girls 9 to 14 Years V503 at Months 0, 2, and 6
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
Активный компаратор: Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Временное ограничение: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Временное ограничение: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 24
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Временное ограничение: Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 24
|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Временное ограничение: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 36
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Временное ограничение: Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 36
|
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.
Общие публикации
- Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
- Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
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 (Действительный)
12 декабря 2013 г.
Первичное завершение (Действительный)
19 июня 2015 г.
Завершение исследования (Действительный)
24 июля 2017 г.
Даты регистрации исследования
Первый отправленный
8 ноября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
14 ноября 2013 г.
Первый опубликованный (Оценивать)
15 ноября 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 августа 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июля 2018 г.
Последняя проверка
1 июля 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- V503-010 (Другой идентификатор: Merck Protocol Number)
- 2013-001314-15 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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