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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02878330
Registration number
NCT02878330
Ethics application status
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
14/10/2019
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
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Scientific title
A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
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Secondary ID [1]
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D5290C00003
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Universal Trial Number (UTN)
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Trial acronym
MEDI8897 Ph2b
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
0
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Other infectious diseases
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Infection
0
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MEDI8897
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Experimental: MEDI8897 50 mg - Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Treatment: Drugs: MEDI8897
A single IM dose of 50 mg on Day 1 of the study.
Treatment: Drugs: Placebo
A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
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Assessment method [1]
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The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
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Timepoint [1]
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From Day 1 through Day 151
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Secondary outcome [1]
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Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
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Assessment method [1]
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A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).
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Timepoint [1]
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From Day 1 through Day 151
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Secondary outcome [2]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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Assessment method [2]
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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. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 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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Timepoint [2]
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From Day 1 through Day 361
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Secondary outcome [3]
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Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
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Assessment method [3]
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An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.
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Timepoint [3]
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From Day 1 through Day 361
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Secondary outcome [4]
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Serum Concentration of MEDI8897
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Assessment method [4]
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Timepoint [4]
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Days 91, 151, and 361
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Secondary outcome [5]
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Elimination Half-life (t1/2) of MEDI8897
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Assessment method [5]
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Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.
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Timepoint [5]
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Day 91 through Day 361
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Secondary outcome [6]
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Number of Participants With Positive Anti-drug Antibodies to MEDI8897
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Assessment method [6]
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The number of participants with positive serum antibodies to MEDI8897 are reported.
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Timepoint [6]
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Days 91, 151, and 361
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Eligibility
Key inclusion criteria
Key
1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
2. Infants who are entering their first full RSV season at the time of screening.
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Minimum age
No limit
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Maximum age
365
Days
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive
commercial palivizumab.
2. Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness
within 7 days prior to randomization.
3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at
the time of randomization.
4. Active RSV infection (a child with signs/symptoms of respiratory infection must have
negative RSV testing) or known prior history of RSV infection.
5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including
maternal RSV vaccination.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2016
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Date of last participant enrolment
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Date of last data collection
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Actual
6/12/2018
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Sample size
Target
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Final
1453
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Parkville
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Research Site - Subiaco
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3052 - Parkville
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6008 - Subiaco
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Funding & Sponsors
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Commercial sector/Industry
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Name
MedImmune LLC
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29
and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV)
season.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02878330
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02878330
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