Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/study/NCT03979313




Registration number
NCT03979313
Ethics application status
Date submitted
30/05/2019
Date registered
7/06/2019
Date last updated
28/02/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
Scientific title
A Phase 3 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 Late Preterm and Term Infants (MELODY)
Secondary ID [1] 0 0
2019-000114-11
Secondary ID [2] 0 0
D5290C00004
Universal Trial Number (UTN)
Trial acronym
MELODY
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
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Timepoint [1] 0 0
Through 150 Days Post Dose
Secondary outcome [1] 0 0
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Timepoint [1] 0 0
Through 150 Days Post Dose
Secondary outcome [2] 0 0
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Timepoint [2] 0 0
By visit until day 360 post dose
Secondary outcome [3] 0 0
Anti-drug Antibody Results by Visit (As Treated Population)
Timepoint [3] 0 0
From baseline to 360 day post dose visit

Eligibility
Key inclusion criteria
Key

* Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
* Infants who are entering their first RSV season at the time of screening

Key
Minimum age
0 Years
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Meets national or other local criteria to receive commercial palivizumab
* Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* 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 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
23/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2023
Sample size
Target
Accrual to date
Final
3012
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
San Miguel de Tucuman
Country [34] 0 0
Austria
State/province [34] 0 0
Graz
Country [35] 0 0
Austria
State/province [35] 0 0
Vienna
Country [36] 0 0
Belgium
State/province [36] 0 0
Brugge
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Bruxelles
Country [39] 0 0
Belgium
State/province [39] 0 0
Gent
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Montana
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Pazardzhik
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Pleven
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Plovdiv
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Ruse
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Sofia
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Veliko Tarnovo
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
Chile
State/province [50] 0 0
Santiago
Country [51] 0 0
Colombia
State/province [51] 0 0
Cali
Country [52] 0 0
Colombia
State/province [52] 0 0
Chia
Country [53] 0 0
Colombia
State/province [53] 0 0
Medellin
Country [54] 0 0
Colombia
State/province [54] 0 0
Monteria
Country [55] 0 0
Colombia
State/province [55] 0 0
Soledad
Country [56] 0 0
Czechia
State/province [56] 0 0
Havlickuv Brod
Country [57] 0 0
Estonia
State/province [57] 0 0
Paide
Country [58] 0 0
Estonia
State/province [58] 0 0
Tallinn
Country [59] 0 0
Estonia
State/province [59] 0 0
Tartu
Country [60] 0 0
Finland
State/province [60] 0 0
Espoo
Country [61] 0 0
Finland
State/province [61] 0 0
Helsinki
Country [62] 0 0
Finland
State/province [62] 0 0
Jarvenpaa
Country [63] 0 0
Finland
State/province [63] 0 0
Kokkola
Country [64] 0 0
Finland
State/province [64] 0 0
Oulu
Country [65] 0 0
Finland
State/province [65] 0 0
Pori
Country [66] 0 0
Finland
State/province [66] 0 0
Seinäjoki
Country [67] 0 0
Finland
State/province [67] 0 0
Tampere
Country [68] 0 0
Finland
State/province [68] 0 0
Turku
Country [69] 0 0
France
State/province [69] 0 0
Amiens Cedex 1
Country [70] 0 0
France
State/province [70] 0 0
Bordeaux
Country [71] 0 0
France
State/province [71] 0 0
Brest
Country [72] 0 0
France
State/province [72] 0 0
Bron
Country [73] 0 0
France
State/province [73] 0 0
Caen
Country [74] 0 0
France
State/province [74] 0 0
Creteil Cedex
Country [75] 0 0
France
State/province [75] 0 0
Lille
Country [76] 0 0
Germany
State/province [76] 0 0
Frankenthal
Country [77] 0 0
Germany
State/province [77] 0 0
Leipzig
Country [78] 0 0
Germany
State/province [78] 0 0
Mannheim
Country [79] 0 0
Israel
State/province [79] 0 0
Beer-Sheva
Country [80] 0 0
Israel
State/province [80] 0 0
Netanya
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Japan
State/province [82] 0 0
Fukuyama-shi
Country [83] 0 0
Japan
State/province [83] 0 0
Kawasaki-shi
Country [84] 0 0
Japan
State/province [84] 0 0
Maebashi-shi
Country [85] 0 0
Japan
State/province [85] 0 0
Okayama-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Osaka-shi
Country [87] 0 0
Japan
State/province [87] 0 0
Sapporo-shi
Country [88] 0 0
Japan
State/province [88] 0 0
Shizuoka-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Yokosuka-shi
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Incheon
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Seoul
Country [92] 0 0
Latvia
State/province [92] 0 0
Jekabpils
Country [93] 0 0
Latvia
State/province [93] 0 0
Riga
Country [94] 0 0
Latvia
State/province [94] 0 0
Valmiera
Country [95] 0 0
Lithuania
State/province [95] 0 0
Kaunas
Country [96] 0 0
Mexico
State/province [96] 0 0
Mexico
Country [97] 0 0
New Zealand
State/province [97] 0 0
Christchurch
Country [98] 0 0
New Zealand
State/province [98] 0 0
Grafton
Country [99] 0 0
New Zealand
State/province [99] 0 0
Papatoetoe
Country [100] 0 0
New Zealand
State/province [100] 0 0
Wellington
Country [101] 0 0
Panama
State/province [101] 0 0
Chorrera
Country [102] 0 0
Panama
State/province [102] 0 0
Cuidad De Panama
Country [103] 0 0
Panama
State/province [103] 0 0
David
Country [104] 0 0
Panama
State/province [104] 0 0
Panama City
Country [105] 0 0
Panama
State/province [105] 0 0
Panama
Country [106] 0 0
Poland
State/province [106] 0 0
Krakow
Country [107] 0 0
Poland
State/province [107] 0 0
Kraków
Country [108] 0 0
Poland
State/province [108] 0 0
Leczna
Country [109] 0 0
Poland
State/province [109] 0 0
Torun
Country [110] 0 0
Poland
State/province [110] 0 0
Wroclaw
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Perm
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Saint Petersburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
St Petersburg
Country [114] 0 0
South Africa
State/province [114] 0 0
Cape Town
Country [115] 0 0
South Africa
State/province [115] 0 0
Durban
Country [116] 0 0
South Africa
State/province [116] 0 0
Johannesburg
Country [117] 0 0
South Africa
State/province [117] 0 0
Pretoria
Country [118] 0 0
South Africa
State/province [118] 0 0
Rondebosch
Country [119] 0 0
South Africa
State/province [119] 0 0
Soweto
Country [120] 0 0
Spain
State/province [120] 0 0
Alicante
Country [121] 0 0
Spain
State/province [121] 0 0
Antequera
Country [122] 0 0
Spain
State/province [122] 0 0
Castellon de la Plana
Country [123] 0 0
Spain
State/province [123] 0 0
Cordoba
Country [124] 0 0
Spain
State/province [124] 0 0
Granada
Country [125] 0 0
Spain
State/province [125] 0 0
La Laguna
Country [126] 0 0
Spain
State/province [126] 0 0
Leganes
Country [127] 0 0
Spain
State/province [127] 0 0
Lleida
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid
Country [129] 0 0
Spain
State/province [129] 0 0
Malaga
Country [130] 0 0
Spain
State/province [130] 0 0
Mostoles
Country [131] 0 0
Spain
State/province [131] 0 0
Pozuelo de Alarcon
Country [132] 0 0
Spain
State/province [132] 0 0
San Juan de Alicante
Country [133] 0 0
Spain
State/province [133] 0 0
Sant Cugat del Valles
Country [134] 0 0
Spain
State/province [134] 0 0
Santiago de Compostela
Country [135] 0 0
Spain
State/province [135] 0 0
Valencia
Country [136] 0 0
Sweden
State/province [136] 0 0
Linköping
Country [137] 0 0
Sweden
State/province [137] 0 0
Stockholm
Country [138] 0 0
Turkey
State/province [138] 0 0
Adana
Country [139] 0 0
Turkey
State/province [139] 0 0
Ankara
Country [140] 0 0
Turkey
State/province [140] 0 0
Izmir
Country [141] 0 0
Turkey
State/province [141] 0 0
Kocaeli
Country [142] 0 0
Ukraine
State/province [142] 0 0
Chernivts?
Country [143] 0 0
Ukraine
State/province [143] 0 0
Dnipro
Country [144] 0 0
Ukraine
State/province [144] 0 0
Kyiv
Country [145] 0 0
Ukraine
State/province [145] 0 0
Sumy
Country [146] 0 0
Ukraine
State/province [146] 0 0
Vinnytsia
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Liverpool
Country [148] 0 0
United Kingdom
State/province [148] 0 0
London

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 efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Trial website
https://clinicaltrials.gov/study/NCT03979313
Trial related presentations / publications
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
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/study/NCT03979313