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 2022 |
| 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 | 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
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,
| 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 |
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