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Клиническое исследование новой пневмококковой вакцины V118C у детей (V118C-002)

30 сентября 2026 г. обновлено: Merck Sharp & Dohme LLC

Фаза 1, рандомизированное, двойное слепое, контролируемое активным компаратором исследование по оценке безопасности, переносимости и иммуногенности новой пневмококковой вакцины у детей

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.

This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).

Тип исследования

Интервенционный

Регистрация (Оцененный)

210

Фаза

  • Фаза 1

Контакты и местонахождение

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

Контакты исследования

  • Имя: Toll Free Number
  • Номер телефона: 1-888-577-8839
  • Электронная почта: Trialsites@msd.com

Места учебы

  • Соединенные Штаты
    • California
      • Madera, California, Соединенные Штаты, 93637
        • Рекрутинг
        • Madera Family Medical Group ( Site 1004)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 559-673-3000
    • Florida
      • Miami, Florida, Соединенные Штаты, 33142
        • Рекрутинг
        • Acevedo Clinical Research Associates ( Site 1029)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 305-649-8871
      • Tampa, Florida, Соединенные Штаты, 33606
        • Рекрутинг
        • University of South Florida-Department of Pediatrics ( Site 1002)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 813-821-8039
    • Kansas
      • Topeka, Kansas, Соединенные Штаты, 66604
        • Рекрутинг
        • Cotton O'Neil Research Center ( Site 1039)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 785-354-6000
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40202
        • Рекрутинг
        • University of Louisville, Norton Children's Research Institute ( Site 1005)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 502-629-5820
    • Maryland
      • Columbia, Maryland, Соединенные Штаты, 21045
        • Рекрутинг
        • The Pediatric Center ( Site 1025)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 443-721-7224
    • Missouri
      • St Louis, Missouri, Соединенные Штаты, 63104
        • Рекрутинг
        • Saint Louis University Center for Vaccine Development ( Site 1031)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 314-977-6333
    • New York
      • East Syracuse, New York, Соединенные Штаты, 13057
        • Рекрутинг
        • Child Health Care Associates ( Site 1035)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 315-652-8800
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты, 29414
        • Рекрутинг
        • Carolina Family Care ( Site 1021)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 843-870-2225
      • Greenville, South Carolina, Соединенные Штаты, 29607
        • Рекрутинг
        • Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 864-334-0141
      • Spartanburg, South Carolina, Соединенные Штаты, 29301
        • Рекрутинг
        • Tribe Clinical Research - Spartanburg ( Site 1001)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 864-334-0141
    • Texas
      • Carrollton, Texas, Соединенные Штаты, 75006
        • Рекрутинг
        • Epic Medical Research - Carrollton ( Site 1038)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 972-777-6956
      • Garland, Texas, Соединенные Штаты, 75043
        • Рекрутинг
        • Epic Medical Research- Garland ( Site 1017)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 972-777-6956
      • League City, Texas, Соединенные Штаты, 77573
        • Рекрутинг
        • University of Texas Medical Branch ( Site 1020)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 832-340-2313
    • Virginia
      • Charlottesville, Virginia, Соединенные Штаты, 22902
        • Рекрутинг
        • Pediatric Research of Charlottesville, LLC ( Site 1012)
        • Контакт:
          • Study Coordinator
          • Номер телефона: 434-872-9384

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 2 месяца до 1 год (Ребенок)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Stage 1:

  • Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
  • Is 12 through 15 months of age

Stage 2:

- Is approximately 2 months of age

Both Stages:

  • Was born at full term (gestational age greater than or equal to 37 weeks)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Stage 1:

- Has received a PCV dose at 10 months of age and older

Stage 2:

  • Has received prior administration of any pneumococcal vaccine

Both stages:

  • Has a history of invasive pneumococcal disease (IPD)
  • Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid

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: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: V118C (Stage 1)

Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
Биологический: V118C (Stage 1)

IM administration of V118C
Экспериментальный: V118C (Stage 2)

Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
Биологический: V118C (Stage 2)

IM administration of V118C
Активный компаратор: PCV20 (Stage 1)

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
Биологический: PCV20 (Stage 1)

IM administration of PCV20
Активный компаратор: PCV20 (Stage 2)

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.
Биологический: PCV20 (Stage 2)

IM administration of PCV20

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Временное ограничение: Up to approximately 30 minutes postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Up to approximately 30 minutes postvaccination
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Временное ограничение: Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Up to approximately 7 days postvaccination
Stage 1: Percentage of Participants With Solicited Systemic AEs
Временное ограничение: Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
Up to approximately 7 days postvaccination
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Временное ограничение: Up to approximately 28 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Up to approximately 28 days postvaccination
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
Временное ограничение: Up to approximately 12 months postvaccination

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Up to approximately 12 months postvaccination
Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
Временное ограничение: Up to approximately 12 months postvaccination

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Up to approximately 12 months postvaccination
Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
Временное ограничение: Up to approximately 30 minutes after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Up to approximately 30 minutes after each vaccination
Stage 2: Percentage of Participants With Solicited Injection-Site AEs
Временное ограничение: Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Up to approximately 7 days after each vaccination
Stage 2: Percentage of Participants With Solicited Systemic AEs
Временное ограничение: Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.
Up to approximately 7 days after each vaccination
Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Временное ограничение: Up to approximately 28 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Up to approximately 28 days after each vaccination
Stage 2: Percentage of Participants With SAEs
Временное ограничение: Up to approximately 12 months postdose 4

A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Up to approximately 12 months postdose 4
Stage 2: Percentage of Participants With MAAEs
Временное ограничение: Up to approximately 12 months postdose 4

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Up to approximately 12 months postdose 4

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Временное ограничение: Up to approximately 30 days post vaccination

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of Serotype-specific IgG at 30 days postvaccination with V118C and PCV20 will be reported.
Up to approximately 30 days post vaccination
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
Временное ограничение: Approximately Day 30 postvaccination

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of GMCs of serotype-specific IgG of V118C to PCV20 will be reported.
Approximately Day 30 postvaccination
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Временное ограничение: Day 1 (Baseline) and approximately Day 30 postvaccination

Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. GMFRs of serotype-specific IgG from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Day 1 (Baseline) and approximately Day 30 postvaccination
Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
Временное ограничение: Day 1 (Baseline) and approximately Day 30 postvaccination

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Day 1 (Baseline) and approximately Day 30 postvaccination
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3
Временное ограничение: Up to approximately 30 days postdose 3

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 3 (PD3) with V118C and PCV20 will be reported will be reported.
Up to approximately 30 days postdose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4
Временное ограничение: Up to approximately 6 months post dose 3

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at predose 4 (PD4) with V118C and PCV20 will be reported.
Up to approximately 6 months post dose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4
Временное ограничение: Up to approximately 30 days postdose 4

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3
Временное ограничение: Up to approximately 30 days postdose 3

Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 3 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 3
Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4
Временное ограничение: Up to approximately 30 days postdose 4

Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3
Временное ограничение: Up to approximately 30 days postdose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of serotype-specific IgG at 30 days postdose 3 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4
Временное ограничение: Up to approximately 6 months post dose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days predose 4 with V118C and PCV20 will be reported.
Up to approximately 6 months post dose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4
Временное ограничение: Up to approximately 30 days postdose 4

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 3
Временное ограничение: Up to approximately 30 days postdose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 3 will be reported.
Up to approximately 30 days postdose 3
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 4
Временное ограничение: Up to approximately 30 days postdose 4

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 4 will be reported.
Up to approximately 30 days postdose 4

Соавторы и исследователи

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

Спонсор

Merck Sharp & Dohme LLC

Следователи

  • Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC

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 (Действительный)

13 января 2026 г.

Первичное завершение (Оцененный)

24 октября 2028 г.

Завершение исследования (Оцененный)

25 мая 2029 г.

Даты регистрации исследования

Первый отправленный

10 декабря 2025 г.

Впервые представлено, что соответствует критериям контроля качества

10 декабря 2025 г.

Первый опубликованный (Действительный)

23 декабря 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

2 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • V118C-002

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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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