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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02878330




Registration number
NCT02878330
Ethics application status
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
20/12/2018

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.
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
Secondary ID [1] 0 0
D5290C00003
Universal Trial Number (UTN)
Trial acronym
MEDI8897 Ph2b
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI8897
Treatment: Drugs - Placebo

Experimental: MEDI8897 - Anti-RSV monoclonal antibody with an extended half-life

Placebo Comparator: Placebo - Commercially available 0.9% (w/v) saline.


Treatment: Drugs: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life

Treatment: Drugs: Placebo
Commercially available 0.9% (w/v) saline.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of medically attended LRTI due to RT-PCR confirmed RSV - The incidence of RSV LRTI (inpatient and outpatient) 150 days post dose will be based on RSV test results (performed centrally via RT-PCR) and objective clinical LRTI criteria and will be summarized by treatment group.
Timepoint [1] 0 0
150 days post dose
Secondary outcome [1] 0 0
Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV - The incidence of RSV hospitalization 150 days post dose will be summarized by treatment group.
Timepoint [1] 0 0
150 days post dose
Secondary outcome [2] 0 0
Safety and tolerability as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) - Safety of MEDI8897 will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs.
Other safety assessments will include the occurence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).
Timepoint [2] 0 0
360 days post dose
Secondary outcome [3] 0 0
Single-dose serum concentrations of MEDI8897 - MEDI8897 serum concentration data will be tabulated by treatment group along with descriptive statistics. Terminal-phase half-life (t1/2) will be estimated using non-compartmental analysis, if data permit.
Timepoint [3] 0 0
360 days post dose
Secondary outcome [4] 0 0
Incidence of anti-drug antibody (ADA) to MEDI8897 in serum - The incidence of ADA to MEDI8897 will be assessed and summarized by number and percentage of subjects that are ADA positive by treatment group.
Timepoint [4] 0 0
360 days post dose

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

Key
Minimum age
No limit
Maximum age
365 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment hospital [2] 0 0
Research Site - Subiaco
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

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 and entering their first RSV season.
Trial website
https://clinicaltrials.gov/show/NCT02878330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications