Clinical trial NCT03979313: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus
RSV
Late Preterm Infants
Healthy Infants
Lower Respiratory Tract Infection
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 3012
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.

Eligibility criteria: Key Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
timeFrame: Through 150 Days Post Dose
Secondary outcomes:
measure: Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
timeFrame: Through 150 Days Post Dose
measure: Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
timeFrame: By visit until day 360 post dose
measure: Anti-drug Antibody Results by Visit (As Treated Population)
timeFrame: From baseline to 360 day post dose visit
Other outcomes:
measure: Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
timeFrame: Through 150 Days Post Dose
measure: Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
timeFrame: Through 150 Days Post Dose
measure: Number of Participants With Disease From the 2nd RSV Season (All Subjects)
timeFrame: From Day 361 to Day 510 Post Dose
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Fort Defiance
country: United States
facility: Research Site
state: Arizona
city: Fayetteville
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Downey
country: United States
facility: Research Site
state: California
city: National City
country: United States
facility: Research Site
state: California
city: Paramount
country: United States
facility: Research Site
state: California
city: West Covina
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Fort Gordon
country: United States
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state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Oak Lawn
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: West Des Moines
country: United States
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state: Iowa
city: Bardstown
country: United States
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state: Kentucky
city: Lexington
country: United States
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state: Kentucky
city: Shreveport
country: United States
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state: Louisiana
city: Jackson
country: United States
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state: Mississippi
city: Columbia
country: United States
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state: Missouri
city: Lincoln
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Gallup
country: United States
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state: New Mexico
city: Shiprock
country: United States
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city: Syracuse
country: United States
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city: Boone
country: United States
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city: Cincinnati
country: United States
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city: Cleveland
country: United States
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city: Cleveland
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city: Columbus
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city: Dayton
country: United States
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city: Dayton
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city: Oklahoma City
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city: Erie
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city: Pittsburgh
country: United States
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city: Warwick
country: United States
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city: North Charleston
country: United States
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state: South Carolina
city: Sioux Falls
country: United States
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city: Kingsport
country: United States
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state: Tennessee
city: Memphis
country: United States
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city: Tullahoma
country: United States
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city: Baytown
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city: Dallas
country: United States
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city: Edinburg
country: United States
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state: Texas
city: League City
country: United States
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city: Longview
country: United States
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city: Pearland
country: United States
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city: San Antonio
country: United States
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city: San Antonio
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city: Tomball
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city: Layton
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city: Roy
country: United States
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city: Saint George
country: United States
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city: Salt Lake City
country: United States
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city: Salt Lake City
country: United States
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city: South Jordan
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city: Richmond
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city: Morgantown
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city: San Miguel de Tucuman
country: Argentina
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country: Argentina
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country: Australia
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country: Australia
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city: Graz
country: Austria
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country: Austria
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city: Brugge
country: Belgium
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city: Brussels
country: Belgium
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city: Brussels
country: Belgium
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city: Bruxelles
country: Belgium
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city: Gent
country: Belgium
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city: Montana
country: Bulgaria
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city: Pazardzhik
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
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city: Sofia
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
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state: British Columbia
city: Pierrefonds
country: Canada
facility: Research Site
state: Quebec
city: Santiago
country: Chile
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Chia
country: Colombia
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city: Medellin
country: Colombia
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city: Medellin
country: Colombia
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city: Monteria
country: Colombia
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city: Soledad
country: Colombia
facility: Research Site
city: Havlickuv Brod
country: Czechia
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city: Paide
country: Estonia
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city: Tallinn
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
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city: Espoo
country: Finland
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city: Helsinki
country: Finland
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city: Jarvenpaa
country: Finland
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city: Kokkola
country: Finland
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city: Oulu
country: Finland
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country: Finland
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city: Seinäjoki
country: Finland
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city: Tampere
country: Finland
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country: Finland
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city: Amiens Cedex 1
country: France
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city: Bordeaux
country: France
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city: Brest
country: France
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city: Bron
country: France
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city: Caen
country: France
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city: Creteil Cedex
country: France
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city: Lille
country: France
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city: Frankenthal
country: Germany
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city: Leipzig
country: Germany
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city: Mannheim
country: Germany
facility: Research Site
city: Beer-Sheva
country: Israel
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city: Netanya
country: Israel
facility: Research Site
city: Roma
country: Italy
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city: Fukuyama-shi
country: Japan
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city: Kawasaki-shi
country: Japan
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country: Japan
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city: Okayama-shi
country: Japan
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country: Japan
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city: Sapporo-shi
country: Japan
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city: Shizuoka-shi
country: Japan
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city: Yokosuka-shi
country: Japan
facility: Research Site
city: Incheon
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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country: Latvia
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city: Riga
country: Latvia
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city: Riga
country: Latvia
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city: Valmiera
country: Latvia
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city: Valmiera
country: Latvia
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city: Kaunas
country: Lithuania
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country: Lithuania
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city: Mexico
country: Mexico
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country: New Zealand
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country: New Zealand
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city: Papatoetoe
country: New Zealand
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city: Wellington
country: New Zealand
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country: Panama
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city: Cuidad De Panama
country: Panama
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city: David
country: Panama
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city: Panama City
country: Panama
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city: Panama
country: Panama
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city: Krakow
country: Poland
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city: Kraków
country: Poland
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city: Leczna
country: Poland
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city: Toruń
country: Poland
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city: Wroclaw
country: Poland
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city: Wrocław
country: Poland
facility: Research Site
city: Perm
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
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city: St Petersburg
country: Russian Federation
facility: Research Site
city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
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city: Johannesburg
country: South Africa
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city: Johannesburg
country: South Africa
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city: Pretoria
country: South Africa
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city: Pretoria
country: South Africa
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city: Rondebosch
country: South Africa
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city: Soweto
country: South Africa
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city: Alicante
country: Spain
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city: Antequera
country: Spain
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city: Castellon de la Plana
country: Spain
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city: Cordoba
country: Spain
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city: Granada
country: Spain
facility: Research Site
city: La Laguna
country: Spain
facility: Research Site
city: Leganes
country: Spain
facility: Research Site
city: Lleida
country: Spain
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city: Madrid
country: Spain
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city: Malaga
country: Spain
facility: Research Site
city: Mostoles
country: Spain
facility: Research Site
city: Pozuelo de Alarcon
country: Spain
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city: San Juan de Alicante
country: Spain
facility: Research Site
city: Sant Cugat del Valles
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Chernivtsі
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.