NCT00121108

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,127

participants targeted

Target at P75+ for phase_3 healthy

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2010

Completed
11 years until next milestone

Results Posted

Study results publicly available

January 5, 2022

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

6.1 years

First QC Date

July 13, 2005

Results QC Date

December 7, 2021

Last Update Submit

December 7, 2021

Conditions

Healthy

Keywords

RSV, infants, Native American Indians

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization

    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

Secondary Outcomes (10)

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    From study Day 0 through study Day 150

  • Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI)

    From study Day 0 through study Day 150

  • Number of Participants With Medically Attended-Otitis Media (MA-OM) Events

    From study Day 0 through study Day 150

  • Number of Participants With Frequency of MA-OM Events

    From study Day 0 through study Day 150

  • Number of Participants With Medically Attended Wheezing Episodes

    From first year through 3 years

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Motavizumab

ACTIVE COMPARATOR

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.

Biological: Motavizumab

Interventions

MotavizumabBIOLOGICAL

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.

Also known as: MEDI-524
Motavizumab
PlaceboOTHER

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.

Placebo

Eligibility Criteria

Age0 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Chinle, Arizona, United States

Location

Research Site

Cibecue, Arizona, United States

Location

Research Site

Fort Definace, Arizona, United States

Location

Research Site

San Carlos, Arizona, United States

Location

Research Site

Tuba City, Arizona, United States

Location

Research Site

Whiteriver, Arizona, United States

Location

Research Site

Winslow, Arizona, United States

Location

Research Site

Baltimore, Maryland, 21205, United States

Location

Research Site

Bloomfield, New Mexico, United States

Location

Research Site

Crownpoint, New Mexico, United States

Location

Research Site

Gallup, New Mexico, United States

Location

Research Site

Shiprock, New Mexico, United States

Location

Related Publications (1)

  • O'Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, Millar EV, Jensen KM, Harris BS, Reid R, Moulton LH, Losonsky GA, Karron RA, Santosham M; Respiratory Syncytial Virus (RSV) Prevention study group. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial. Lancet Infect Dis. 2015 Dec;15(12):1398-408. doi: 10.1016/S1473-3099(15)00247-9. Epub 2015 Nov 4.

    PMID: 26511956DERIVED

MeSH Terms

Interventions

motavizumab

Results Point of Contact

Title
Global Clinical Lead
Organization
AstraZeneca Clinical study Information Center
information.center@astrazeneca.com
1-877-240-9479

Study Officials

  • MedImmune, LLC MedImmune, LLC

    MedImmune LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

November 15, 2004

Primary Completion

December 27, 2010

Study Completion

December 27, 2010

Last Updated

January 5, 2022

Results First Posted

January 5, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
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.
Access Criteria
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.
More information

Locations

US(12)