A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

Respiratory Syncytial Virus Infections Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05238974
• Other study ID #: D5290C00004
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 23, 2019
• Est. completion date: March 23, 2023

Study information

• Verified date: February 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2965
• Est. completion date: March 23, 2023
• Est. primary completion date: March 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Drug:
• MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
• Placebo
Commercially available 0.9% (w/v) saline

Locations

Country	Name	City	State
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	San Miguel de Tucuman
Australia	Research Site	Clayton
Australia	Research Site	Nedlands
Austria	Research Site	Graz
Austria	Research Site	Vienna
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Gent
Bulgaria	Research Site	Montana
Bulgaria	Research Site	Pazardzhik
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Veliko Tarnovo
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Pierrefonds	Quebec
Canada	Research Site	Vancouver	British Columbia
Chile	Research Site	Santiago
Colombia	Research Site	Cali
Colombia	Research Site	Chia
Colombia	Research Site	Medellin
Colombia	Research Site	Medellin
Colombia	Research Site	Monteria
Colombia	Research Site	Soledad
Czechia	Research Site	Havlickuv Brod
Estonia	Research Site	Paide
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Finland	Research Site	Espoo
Finland	Research Site	Helsinki
Finland	Research Site	Jarvenpaa
Finland	Research Site	Kokkola
Finland	Research Site	Oulu
Finland	Research Site	Pori
Finland	Research Site	Seinäjoki
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Amiens Cedex 1
France	Research Site	Bordeaux
France	Research Site	Brest
France	Research Site	Bron
France	Research Site	Caen
France	Research Site	Creteil Cedex
France	Research Site	Lille
Germany	Research Site	Frankenthal
Germany	Research Site	Leipzig
Germany	Research Site	Mannheim
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Gyula
Hungary	Research Site	Kecskemét
Hungary	Research Site	Miskolc
Hungary	Research Site	Miskolc
Hungary	Research Site	Nagykanizsa
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Pécs
Hungary	Research Site	Szekszárd
Hungary	Research Site	Szigetvár
Hungary	Research Site	Veszprém
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Beer-Sheva
Israel	Research Site	Netanya
Italy	Research Site	Roma
Japan	Research Site	Fukuyama-shi
Japan	Research Site	Kawasaki-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Shizuoka-shi
Japan	Research Site	Yokosuka-shi
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Latvia	Research Site	Jekabpils
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Latvia	Research Site	Valmiera
Latvia	Research Site	Valmiera
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Kaunas
Mexico	Research Site	Mexico
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton
New Zealand	Research Site	Papatoetoe
New Zealand	Research Site	Wellington
Panama	Research Site	Chorrera
Panama	Research Site	Cuidad De Panama
Panama	Research Site	David
Panama	Research Site	Panama
Panama	Research Site	Panama City
Poland	Research Site	Krakow
Poland	Research Site	Kraków
Poland	Research Site	Leczna
Poland	Research Site	Torun
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	St Petersburg
Russian Federation	Research Site	St Petersburg
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Johannesburg
South Africa	Research Site	Pretoria
South Africa	Research Site	Pretoria
South Africa	Research Site	Rondebosch
South Africa	Research Site	Soweto
Spain	Research Site	Alicante
Spain	Research Site	Antequera
Spain	Research Site	Castellon de la Plana
Spain	Research Site	Cordoba
Spain	Research Site	Granada
Spain	Research Site	La Laguna
Spain	Research Site	Leganes
Spain	Research Site	Lleida
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Mostoles
Spain	Research Site	Pozuelo de Alarcon
Spain	Research Site	San Juan de Alicante
Spain	Research Site	Sant Cugat del Valles
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Tarragona
Spain	Research Site	Valencia
Sweden	Research Site	Linköping
Sweden	Research Site	Stockholm
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Izmir
Turkey	Research Site	Kocaeli
Ukraine	Research Site	Chernivts?
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Sumy
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Bardstown	Kentucky
United States	Research Site	Baytown	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boone	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Dayton	Ohio
United States	Research Site	Downey	California
United States	Research Site	Edinburg	Texas
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Fayetteville	Arkansas
United States	Research Site	Fort Defiance	Arizona
United States	Research Site	Fort Gordon	Georgia
United States	Research Site	Gainesville	Florida
United States	Research Site	Gallup	New Mexico
United States	Research Site	Hialeah	Florida
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jackson	Mississippi
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Layton	Utah
United States	Research Site	League City	Texas
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Longview	Texas
United States	Research Site	Marshfield	Wisconsin
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Morgantown	West Virginia
United States	Research Site	National City	California
United States	Research Site	North Charleston	South Carolina
United States	Research Site	Oak Lawn	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Paramount	California
United States	Research Site	Pearland	Texas
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Richmond	Virginia
United States	Research Site	Roy	Utah
United States	Research Site	Saint George	Utah
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Shiprock	New Mexico
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	South Jordan	Utah
United States	Research Site	Syracuse	New York
United States	Research Site	Tomball	Texas
United States	Research Site	Tullahoma	Tennessee
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Washington	District of Columbia
United States	Research Site	West Covina	California
United States	Research Site	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  Estonia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  New Zealand,  Panama,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV LRTI will be estimated from model.	150 days post dose
Secondary	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 presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV hospitalization will be estimated from model.	150 days post dose
Secondary	Safety and tolerability of MEDI8897 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 occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).	360 days post dose
Secondary	Single-dose serum concentrations of MEDI8897	MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group.	360 days post dose
Secondary	Incidence of anti-drug antibody (ADA) to MEDI8897 in serum	The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.	360 days post dose