MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
7 dicembre 2021 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
2127
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arizona
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Chinle, Arizona, Stati Uniti
- Research Site
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Cibecue, Arizona, Stati Uniti
- Research Site
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Fort Definace, Arizona, Stati Uniti
- Research Site
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San Carlos, Arizona, Stati Uniti
- Research Site
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Tuba City, Arizona, Stati Uniti
- Research Site
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Whiteriver, Arizona, Stati Uniti
- Research Site
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Winslow, Arizona, Stati Uniti
- Research Site
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Research Site
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New Mexico
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Bloomfield, New Mexico, Stati Uniti
- Research Site
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Crownpoint, New Mexico, Stati Uniti
- Research Site
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Gallup, New Mexico, Stati Uniti
- Research Site
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Shiprock, New Mexico, Stati Uniti
- Research Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 secondo a 6 mesi (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: 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.
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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.
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Comparatore attivo: 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.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization
Lasso di tempo: From study Day 0 through study Day 150
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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.
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From study Day 0 through study Day 150
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Lasso di tempo: From study Day 0 through study Day 150
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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.
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From study Day 0 through study Day 150
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Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)
Lasso di tempo: From study Day 0 through study Day 150
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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.
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From study Day 0 through study Day 150
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Number of Participants With Medically Attended-Otitis Media (MA-OM) Events
Lasso di tempo: From study Day 0 through study Day 150
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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.
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From study Day 0 through study Day 150
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Number of Participants With Frequency of MA-OM Events
Lasso di tempo: From study Day 0 through study Day 150
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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.
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From study Day 0 through study Day 150
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Number of Participants With Medically Attended Wheezing Episodes
Lasso di tempo: From first year through 3 years
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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.
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From first year through 3 years
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Number of Participants With Serious Early Childhood Wheezing Episodes
Lasso di tempo: From first year through 3 years
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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.
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From first year through 3 years
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Number of Participants With Frequency of Medically Attended Wheezing Events
Lasso di tempo: Study Day 0 through 3 years
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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.
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Study Day 0 through 3 years
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Mean Trough Serum Concentrations of Motavizumab
Lasso di tempo: Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)
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The mean trough serum concentrations of motavizumab are reported.
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Day 0 (pre Dose 1) and Day 120 (Pre Dose 5)
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Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose
Lasso di tempo: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
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The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported.
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Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
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Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose
Lasso di tempo: Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
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The number of participants with positive serum ADA to motavizumab after any dose are reported.
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Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: MedImmune, LLC MedImmune, LLC, MedImmune LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 novembre 2004
Completamento primario (Effettivo)
27 dicembre 2010
Completamento dello studio (Effettivo)
27 dicembre 2010
Date di iscrizione allo studio
Primo inviato
13 luglio 2005
Primo inviato che soddisfa i criteri di controllo qualità
19 luglio 2005
Primo Inserito (Stima)
21 luglio 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 dicembre 2021
Ultimo verificato
1 dicembre 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- MI-CP117
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .