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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

2021년 12월 7일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

2127

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1초 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.
다른: 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.
활성 비교기: 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.
생물학적: 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.
다른 이름들:
  • 메디-524

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

MedImmune LLC

수사관

  • 연구 책임자: MedImmune, LLC MedImmune, LLC, MedImmune LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2004년 11월 15일

기본 완료 (실제)

2010년 12월 27일

연구 완료 (실제)

2010년 12월 27일

연구 등록 날짜

최초 제출

2005년 7월 13일

QC 기준을 충족하는 최초 제출

2005년 7월 19일

처음 게시됨 (추정)

2005년 7월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 7일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • MI-CP117

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구 프로토콜
  • 통계 분석 계획(SAP)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Chile

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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