Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03959488




Registration number
NCT03959488
Ethics application status
Date submitted
21/05/2019
Date registered
22/05/2019
Date last updated
21/09/2023

Titles & IDs
Public title
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
Scientific title
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
Secondary ID [1] 0 0
2019-000201-69
Secondary ID [2] 0 0
D5290C00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

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

Active Comparator: Palivizumab - anti-RSV monoclonal antibody


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

Treatment: Drugs: Palivizumab
Approved anti-RSV monoclonal antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
Timepoint [1] 0 0
360 days post first dose
Secondary outcome [1] 0 0
Serum Concentrations of MEDI8897 and Palivizumab
Timepoint [1] 0 0
Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Secondary outcome [2] 0 0
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
Timepoint [2] 0 0
360 days post first dose
Secondary outcome [3] 0 0
Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose
Timepoint [3] 0 0
150 days post first dose

Eligibility
Key inclusion criteria
Inclusion criteria

1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant
CHD): preterm infants in their first year of life and born = 35 weeks 0 days GA
eligible to receive palivizumab in accordance with national or local guidelines,
including those with:

1. Uncomplicated small atrial or ventricular septal defects or patent ductus
arteriosus, or

2. Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone

2. For the CLD/CHD cohort:

1. Subjects with CLD - infants in their first year of life and a diagnosis of CLD of
prematurity requiring medical intervention/management (ie, supplemental oxygen,
bronchodilators, or diuretics) within the 6 months prior to randomization

2. Subjects with CHD - infants in their first year of life and documented,
hemodynamically significant CHD (must be unoperated or partially corrected CHD)
Note: Infants with hemodynamically significant acyanotic cardiac lesions must
have pulmonary hypertension (= 40 mmHg measured pressure in the pulmonary artery)
or the need for daily medication to manage CHD

3. Infants who are entering their first RSV season at the time of screening

4. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU)
obtained from the subject's parent(s)/legal representative(s) prior to performing any
protocol-related procedures, including screening evaluations

5. Subject's parent(s)/legal representative(s) able to understand and comply with the
requirements of the protocol including follow-up and illness visits as judged by the
investigator

6. Subject is available to complete the follow-up period, which will be 1 year after
Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or
last replacement dose as applicable for CHD) for subjects with CLD/CHD
Minimum age
0 Years
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days
prior to randomization

2. Any history of LRTI or active LRTI prior to, or at the time of, randomization

3. Known history of RSV infection or active RSV infection prior to, or at the time of,
randomization

4. Hospitalization at the time of randomization, unless discharge is expected within the
7 days after randomization

5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or
other mechanical respiratory or cardiac support at the time of randomization

6. Anticipated cardiac surgery within 2 weeks after randomization

7. Anticipated survival of < 6 months after randomization

8. Receipt of any investigational drug

9. Known renal impairment

10. Known hepatic dysfunction including known or suspected active or chronic hepatitis
infection

11. Clinically significant congenital anomaly of the respiratory tract

12. Chronic seizure, or evolving or unstable neurologic disorder

13. Prior history of a suspected or actual acute life-threatening event

14. Known immunodeficiency, including human immunodeficiency virus (HIV)

15. Mother with HIV infection (unless the child has been proven to be not infected)

16. Any known allergy, including to immunoglobulin products, or history of allergic
reaction

17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV
vaccination

18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune
globulin, intravenous immunoglobulin) or anticipated use during the study

19. Any condition that, in the opinion of the investigator, would interfere with
evaluation of the study drug or interpretation of subject safety or study results

20. Concurrent enrollment in another interventional study

21. Children of employees of the sponsor, clinical study site, or any other individuals
involved with the conduct of the study, or immediate family members of such
individuals

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/Phase 3
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
30/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2023
Sample size
Target
Accrual to date
Final
925
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Montana
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Pazardzhik
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Pleven
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Ruse
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sliven
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Veliko Tarnovo
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 4
Country [34] 0 0
Estonia
State/province [34] 0 0
Tallinn
Country [35] 0 0
Estonia
State/province [35] 0 0
Tartu
Country [36] 0 0
Finland
State/province [36] 0 0
Tampere
Country [37] 0 0
France
State/province [37] 0 0
Amiens Cedex 1
Country [38] 0 0
France
State/province [38] 0 0
Bordeaux
Country [39] 0 0
France
State/province [39] 0 0
Brest
Country [40] 0 0
France
State/province [40] 0 0
Bron
Country [41] 0 0
France
State/province [41] 0 0
Caen
Country [42] 0 0
France
State/province [42] 0 0
Creteil Cedex
Country [43] 0 0
France
State/province [43] 0 0
Grenoble Cedex 9
Country [44] 0 0
France
State/province [44] 0 0
Marseille
Country [45] 0 0
France
State/province [45] 0 0
Pau Cedex
Country [46] 0 0
Germany
State/province [46] 0 0
Frankenthal
Country [47] 0 0
Germany
State/province [47] 0 0
Leipzig
Country [48] 0 0
Germany
State/province [48] 0 0
Mannheim
Country [49] 0 0
Hungary
State/province [49] 0 0
Baja
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Debrecen
Country [52] 0 0
Hungary
State/province [52] 0 0
Kecskemét
Country [53] 0 0
Hungary
State/province [53] 0 0
Miskolc
Country [54] 0 0
Italy
State/province [54] 0 0
Pisa
Country [55] 0 0
Italy
State/province [55] 0 0
Verona
Country [56] 0 0
Japan
State/province [56] 0 0
Fukui-shi
Country [57] 0 0
Japan
State/province [57] 0 0
Fukuoka-shi
Country [58] 0 0
Japan
State/province [58] 0 0
Kitakyusyu-shi
Country [59] 0 0
Japan
State/province [59] 0 0
Maebashi-shi
Country [60] 0 0
Japan
State/province [60] 0 0
Saitama shi
Country [61] 0 0
Japan
State/province [61] 0 0
Setagaya-ku
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Ansan-si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Suwon-si
Country [65] 0 0
Latvia
State/province [65] 0 0
Jekabpils
Country [66] 0 0
Latvia
State/province [66] 0 0
Riga
Country [67] 0 0
Lithuania
State/province [67] 0 0
Kaunas
Country [68] 0 0
Mexico
State/province [68] 0 0
Cuernavaca
Country [69] 0 0
Mexico
State/province [69] 0 0
Mexico
Country [70] 0 0
New Zealand
State/province [70] 0 0
Christchurch
Country [71] 0 0
Poland
State/province [71] 0 0
Bydgoszcz
Country [72] 0 0
Poland
State/province [72] 0 0
Gdansk
Country [73] 0 0
Poland
State/province [73] 0 0
Krakow
Country [74] 0 0
Poland
State/province [74] 0 0
Kraków
Country [75] 0 0
Poland
State/province [75] 0 0
Wroclaw
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Kazan
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Novosibirsk
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Perm
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Saint Petersburg
Country [80] 0 0
Russian Federation
State/province [80] 0 0
St Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Yaroslavl
Country [82] 0 0
South Africa
State/province [82] 0 0
Cape Town
Country [83] 0 0
South Africa
State/province [83] 0 0
Johannesburg
Country [84] 0 0
South Africa
State/province [84] 0 0
Pretoria
Country [85] 0 0
South Africa
State/province [85] 0 0
Soweto
Country [86] 0 0
Spain
State/province [86] 0 0
Alicante
Country [87] 0 0
Spain
State/province [87] 0 0
Boadilla del Monte
Country [88] 0 0
Spain
State/province [88] 0 0
Elche
Country [89] 0 0
Spain
State/province [89] 0 0
Leganes
Country [90] 0 0
Spain
State/province [90] 0 0
Lleida
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Malaga
Country [93] 0 0
Spain
State/province [93] 0 0
Pozuelo de Alarcon
Country [94] 0 0
Spain
State/province [94] 0 0
Sant Cugat del Valles
Country [95] 0 0
Spain
State/province [95] 0 0
Tarragona
Country [96] 0 0
Sweden
State/province [96] 0 0
Stockholm
Country [97] 0 0
Turkey
State/province [97] 0 0
Adana
Country [98] 0 0
Turkey
State/province [98] 0 0
Izmir
Country [99] 0 0
Turkey
State/province [99] 0 0
Kocaeli
Country [100] 0 0
Ukraine
State/province [100] 0 0
Chernivts?
Country [101] 0 0
Ukraine
State/province [101] 0 0
Dnipro
Country [102] 0 0
Ukraine
State/province [102] 0 0
Ivano-Frankivsk
Country [103] 0 0
Ukraine
State/province [103] 0 0
Kharkiv Region
Country [104] 0 0
Ukraine
State/province [104] 0 0
Odesa
Country [105] 0 0
Ukraine
State/province [105] 0 0
Sumy
Country [106] 0 0
Ukraine
State/province [106] 0 0
Vinnytsia
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Leicester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
London
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to
palivizumab when administered to preterm infants entering their first RSV season and children
with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and
second RSV season.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03959488
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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03959488