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MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States

7 декабря 2021 г. обновлено: MedImmune LLC

A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season.

Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections.

During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.

Тип исследования

Интервенционный

Регистрация (Действительный)

2127

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

  • Соединенные Штаты
    • Arizona
      • Chinle, Arizona, Соединенные Штаты
        • Research Site
      • Cibecue, Arizona, Соединенные Штаты
        • Research Site
      • Fort Definace, Arizona, Соединенные Штаты
        • Research Site
      • San Carlos, Arizona, Соединенные Штаты
        • Research Site
      • Tuba City, Arizona, Соединенные Штаты
        • Research Site
      • Whiteriver, Arizona, Соединенные Штаты
        • Research Site
      • Winslow, Arizona, Соединенные Штаты
        • Research Site
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21205
        • Research Site
    • New Mexico
      • Bloomfield, New Mexico, Соединенные Штаты
        • Research Site
      • Crownpoint, New Mexico, Соединенные Штаты
        • Research Site
      • Gallup, New Mexico, Соединенные Штаты
        • Research Site
      • Shiprock, New Mexico, Соединенные Штаты
        • Research Site

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 1 секунда до 6 месяцев (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
  • Male or female Native American
  • General state of good health
  • Written informed consent obtained from the participant's parent(s) or legal guardian

Exclusion Criteria:

  • Gestational age less than or equal to 35 weeks
  • Chronic lung disease of prematurity
  • A bleeding diathesis that would preclude IM injections
  • Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
  • Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
  • A documented wheezing episode before enrollment
  • Known renal impairment
  • Known hepatic dysfunction
  • Clinically significant congenital anomaly of the respiratory tract
  • Chronic seizure or evolving or unstable neurologic disorder
  • Congenital heart disease (CHD) (children with uncomplicated CHD [e.g., Patent ductus arteriosus, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
  • Known immunodeficiency
  • Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
  • Known allergy to Ig products
  • Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) within 3 months prior to randomization
  • Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
  • Previous receipt of RSV vaccines
  • Participation in other investigational drug product studies
  • Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
  • Inability to complete the study follow-up period through up to 5 years of age

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: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Другой: Placebo
Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Активный компаратор: Motavizumab
Participants will receive IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
Биологический: Motavizumab
Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
Другие имена:
  • МЕДИ-524

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
Временное ограничение: From study Day 0 through study Day 150
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
From study Day 0 through study Day 150

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: From study Day 0 through study Day 150
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
From study Day 0 through study Day 150
Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)
Временное ограничение: From study Day 0 through study Day 150
The RSV outpatient MA LRI was defined as an outpatient medically attended event designated as a lower respiratory illness with a positive RT-PCR RSV test. An LRI event is one that has a medical diagnosis of bronchiolitis or pneumonia. In the absence of such a medical diagnosis, the occurrence of LRI events was determined by the principal investigator after review of the medical record and considering the presence of cough, retractions, rhonchi, wheezing, crackles, or rales, associated with symptoms (by history or clinical findings) of coryza, fever, or apnoea.
From study Day 0 through study Day 150
Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
Временное ограничение: From study Day 0 through study Day 150
Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event.
From study Day 0 through study Day 150
Number of Participants With Frequency of MA-OM Events
Временное ограничение: From study Day 0 through study Day 150
Otitis media was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute TM perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. Number of participants with frequency of MA-OM events (either 0, 1, 2, 3, or greater than [>] 3) are reported.
From study Day 0 through study Day 150
Number of Participants With Medically Attended Wheezing Episodes
Временное ограничение: From first year through 3 years
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred >2 weeks after the diagnosis of the previous episode and the medical opinion was that the wheezing does not represent a persistence of the previous episode. Number of participants with greater than or equal to (>=) 1 MA wheezing events and >= 3 MA wheezing events occurring from first through 3 years of age are reported.
From first year through 3 years
Number of Participants With Serious Early Childhood Wheezing Episodes
Временное ограничение: From first year through 3 years
Serious early childhood wheezing (SECW) was defined as: three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or a need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or a need for asthma-controller medication over a 12 month period for at least 3 consecutive months (>= 90 days) or 5 cumulative months (>= 150 days) any time from the first through the third birthday, or at least one inpatient wheezing event from the first through the third birthday.
From first year through 3 years
Number of Participants With Frequency of Medically Attended Wheezing Events
Временное ограничение: Study Day 0 through 3 years
Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred >2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Number of participants with frequency of MA wheezing events (either 0, 1, 2, 3, 4, or greater than or equal to [>=] 5) are reported.
Study Day 0 through 3 years
Mean Trough Serum Concentrations of Motavizumab
Временное ограничение: Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)
The mean trough serum concentrations of motavizumab are reported.
Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)
Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose
Временное ограничение: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported.
Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose
Временное ограничение: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
The number of participants with positive serum ADA to motavizumab after any dose are reported.
Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)

Соавторы и исследователи

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

Спонсор

MedImmune LLC

Следователи

  • Директор по исследованиям: MedImmune, LLC MedImmune, LLC, MedImmune LLC

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 (Действительный)

15 ноября 2004 г.

Первичное завершение (Действительный)

27 декабря 2010 г.

Завершение исследования (Действительный)

27 декабря 2010 г.

Даты регистрации исследования

Первый отправленный

13 июля 2005 г.

Впервые представлено, что соответствует критериям контроля качества

19 июля 2005 г.

Первый опубликованный (Оценивать)

21 июля 2005 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 января 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 декабря 2021 г.

Последняя проверка

1 декабря 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • MI-CP117

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Да

Описание плана IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Сроки обмена IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Критерии совместного доступа к IPD

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Совместное использование IPD Поддерживающий тип информации

  • Протокол исследования
  • План статистического анализа (SAP)

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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