Respiratory Syncytial Virus Infections Clinical Trial
— MELODYOfficial 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)
| Verified date | February 2024 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 3012 |
| Est. completion date | March 21, 2023 |
| Est. primary completion date | March 11, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 0 Years 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 |
| 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 | |
| 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 | 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects) | Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants) | Through 150 Days Post Dose | |
| Other | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects) | Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants) | Through 150 Days Post Dose | |
| Other | Number of Participants With Disease From the 2nd RSV Season (All Subjects) | From Day 361 to Day 510 Post Dose | ||
| Primary | Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) | Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants) | Through 150 Days Post Dose | |
| Secondary | Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) | Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants) | Through 150 Days Post Dose | |
| Secondary | Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group | Number of Subjects with at Least one Assessment | By visit until day 360 post dose | |
| Secondary | Anti-drug Antibody Results by Visit (As Treated Population) | Number of subjects with a positive result and a valid titer result at the specific visit | From baseline to 360 day post dose visit |
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