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)
Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03979313
Collaborator
(none)
2,965
215
2
44
13.8
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2965 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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)
Actual Study Start Date
:
Jul 23, 2019
Actual Primary Completion Date
:
Mar 11, 2021
Anticipated Study Completion Date
:
Mar 23, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEDI8897 Anti-RSV monoclonal antibody with an extended half-life |
Drug: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
|
| Placebo Comparator: Placebo Commercially available 0.9% (w/v) saline |
Drug: Placebo
Commercially available 0.9% (w/v) saline
|
Outcome Measures
Primary Outcome Measures
- Incidence of medically attended LRTI due to RT-PCR confirmed RSV [150 days post dose]
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.
Secondary Outcome Measures
- Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV [150 days post dose]
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.
- Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) [360 days post dose]
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).
- Single-dose serum concentrations of MEDI8897 [360 days post dose]
MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group.
- Incidence of anti-drug antibody (ADA) to MEDI8897 in serum [360 days post dose]
The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Years
to 1 Year
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Birmingham | Alabama | United States | 35205 |
| 2 | Research Site | Fort Defiance | Arizona | United States | 86504 |
| 3 | Research Site | Fayetteville | Arkansas | United States | 72703 |
| 4 | Research Site | Anaheim | California | United States | 92804 |
| 5 | Research Site | Downey | California | United States | 90240 |
| 6 | Research Site | National City | California | United States | 91950 |
| 7 | Research Site | Paramount | California | United States | 90723 |
| 8 | Research Site | West Covina | California | United States | 91790 |
| 9 | Research Site | Aurora | Colorado | United States | 80015 |
| 10 | Research Site | Colorado Springs | Colorado | United States | 80922 |
| 11 | Research Site | Washington | District of Columbia | United States | 20016 |
| 12 | Research Site | Gainesville | Florida | United States | 32653 |
| 13 | Research Site | Hialeah | Florida | United States | 33012 |
| 14 | Research Site | Miami | Florida | United States | 33142 |
| 15 | Research Site | Atlanta | Georgia | United States | 30322 |
| 16 | Research Site | Fort Gordon | Georgia | United States | 30905 |
| 17 | Research Site | Chicago | Illinois | United States | 60611 |
| 18 | Research Site | Oak Lawn | Illinois | United States | 60453 |
| 19 | Research Site | Indianapolis | Indiana | United States | 46202 |
| 20 | Research Site | West Des Moines | Iowa | United States | 50266 |
| 21 | Research Site | Bardstown | Kentucky | United States | 40004 |
| 22 | Research Site | Lexington | Kentucky | United States | 40517 |
| 23 | Research Site | Shreveport | Louisiana | United States | 71105 |
| 24 | Research Site | Jackson | Mississippi | United States | 39216 |
| 25 | Research Site | Columbia | Missouri | United States | 65212 |
| 26 | Research Site | Lincoln | Nebraska | United States | 68504 |
| 27 | Research Site | Omaha | Nebraska | United States | 68114 |
| 28 | Research Site | Gallup | New Mexico | United States | 87301 |
| 29 | Research Site | Shiprock | New Mexico | United States | 87420 |
| 30 | Research Site | Syracuse | New York | United States | 13210 |
| 31 | Research Site | Boone | North Carolina | United States | 28607 |
| 32 | Research Site | Cincinnati | Ohio | United States | 45229 |
| 33 | Research Site | Cleveland | Ohio | United States | 44109 |
| 34 | Research Site | Cleveland | Ohio | United States | 44121 |
| 35 | Research Site | Columbus | Ohio | United States | 43205 |
| 36 | Research Site | Dayton | Ohio | United States | 45406 |
| 37 | Research Site | Dayton | Ohio | United States | 45414 |
| 38 | Research Site | Oklahoma City | Oklahoma | United States | 73104 |
| 39 | Research Site | Erie | Pennsylvania | United States | 16506 |
| 40 | Research Site | Pittsburgh | Pennsylvania | United States | 15213 |
| 41 | Research Site | Warwick | Rhode Island | United States | 02886 |
| 42 | Research Site | North Charleston | South Carolina | United States | 29406 |
| 43 | Research Site | Sioux Falls | South Dakota | United States | 57105 |
| 44 | Research Site | Kingsport | Tennessee | United States | 37660 |
| 45 | Research Site | Memphis | Tennessee | United States | 38103 |
| 46 | Research Site | Tullahoma | Tennessee | United States | 37388 |
| 47 | Research Site | Baytown | Texas | United States | 77521 |
| 48 | Research Site | Dallas | Texas | United States | 75251 |
| 49 | Research Site | Edinburg | Texas | United States | 78539 |
| 50 | Research Site | League City | Texas | United States | 77573 |
| 51 | Research Site | Longview | Texas | United States | 75605 |
| 52 | Research Site | Pearland | Texas | United States | 77584 |
| 53 | Research Site | San Antonio | Texas | United States | 78240 |
| 54 | Research Site | San Antonio | Texas | United States | 78249 |
| 55 | Research Site | Tomball | Texas | United States | 77375 |
| 56 | Research Site | Layton | Utah | United States | 84041 |
| 57 | Research Site | Roy | Utah | United States | 84067 |
| 58 | Research Site | Saint George | Utah | United States | 84790 |
| 59 | Research Site | Salt Lake City | Utah | United States | 84107 |
| 60 | Research Site | South Jordan | Utah | United States | 84095 |
| 61 | Research Site | Charlottesville | Virginia | United States | 22902 |
| 62 | Research Site | Richmond | Virginia | United States | 23219 |
| 63 | Research Site | Seattle | Washington | United States | 98105 |
| 64 | Research Site | Morgantown | West Virginia | United States | 26506 |
| 65 | Research Site | Marshfield | Wisconsin | United States | 54449 |
| 66 | Research Site | San Miguel de Tucuman | Argentina | 4000 | |
| 67 | Research Site | San Miguel de Tucuman | Argentina | T4000NWB | |
| 68 | Research Site | Clayton | Australia | 3168 | |
| 69 | Research Site | Nedlands | Australia | 6009 | |
| 70 | Research Site | Graz | Austria | 8036 | |
| 71 | Research Site | Vienna | Austria | 1090 | |
| 72 | Research Site | Brugge | Belgium | 8000 | |
| 73 | Research Site | Brussels | Belgium | 1070 | |
| 74 | Research Site | Brussels | Belgium | 1090 | |
| 75 | Research Site | Bruxelles | Belgium | 1000 | |
| 76 | Research Site | Gent | Belgium | 9000 | |
| 77 | Research Site | Montana | Bulgaria | 3400 | |
| 78 | Research Site | Pazardzhik | Bulgaria | 4400 | |
| 79 | Research Site | Pleven | Bulgaria | 5800 | |
| 80 | Research Site | Plovdiv | Bulgaria | 4000 | |
| 81 | Research Site | Plovdiv | Bulgaria | 4002 | |
| 82 | Research Site | Ruse | Bulgaria | 7002 | |
| 83 | Research Site | Sofia | Bulgaria | 1407 | |
| 84 | Research Site | Veliko Tarnovo | Bulgaria | 5000 | |
| 85 | Research Site | Calgary | Alberta | Canada | T3B 6A8 |
| 86 | Research Site | Vancouver | British Columbia | Canada | V6H 3V4 |
| 87 | Research Site | Pierrefonds | Quebec | Canada | H9H 4Y6 |
| 88 | Research Site | Santiago | Chile | 8880465 | |
| 89 | Research Site | Cali | Colombia | ||
| 90 | Research Site | Chia | Colombia | 250002 | |
| 91 | Research Site | Medellin | Colombia | 50036 | |
| 92 | Research Site | Medellin | Colombia | 500515 | |
| 93 | Research Site | Monteria | Colombia | 230002 | |
| 94 | Research Site | Soledad | Colombia | 083001 | |
| 95 | Research Site | Havlickuv Brod | Czechia | 580 22 | |
| 96 | Research Site | Paide | Estonia | 72713 | |
| 97 | Research Site | Tallinn | Estonia | 10117 | |
| 98 | Research Site | Tallinn | Estonia | 10617 | |
| 99 | Research Site | Tallinn | Estonia | 13419 | |
| 100 | Research Site | Tartu | Estonia | 50406 | |
| 101 | Research Site | Espoo | Finland | 02230 | |
| 102 | Research Site | Helsinki | Finland | 00100 | |
| 103 | Research Site | Jarvenpaa | Finland | 04400 | |
| 104 | Research Site | Kokkola | Finland | 67100 | |
| 105 | Research Site | Oulu | Finland | 90220 | |
| 106 | Research Site | Pori | Finland | 28100 | |
| 107 | Research Site | Seinäjoki | Finland | 60100 | |
| 108 | Research Site | Tampere | Finland | 33100 | |
| 109 | Research Site | Turku | Finland | 20520 | |
| 110 | Research Site | Amiens Cedex 1 | France | 80054 | |
| 111 | Research Site | Bordeaux | France | 33000 | |
| 112 | Research Site | Brest | France | 29609 | |
| 113 | Research Site | Bron | France | 69677 | |
| 114 | Research Site | Caen | France | 14033 | |
| 115 | Research Site | Creteil Cedex | France | 94010 | |
| 116 | Research Site | Lille | France | 59020 | |
| 117 | Research Site | Frankenthal | Germany | 67227 | |
| 118 | Research Site | Leipzig | Germany | 04103 | |
| 119 | Research Site | Mannheim | Germany | 68161 | |
| 120 | Research Site | Baja | Hungary | 6500 | |
| 121 | Research Site | Budapest | Hungary | 1131 | |
| 122 | Research Site | Budapest | Hungary | 1188 | |
| 123 | Research Site | Debrecen | Hungary | 4032 | |
| 124 | Research Site | Gyula | Hungary | 5700 | |
| 125 | Research Site | Győr | Hungary | 9024 | |
| 126 | Research Site | Kecskemét | Hungary | 6000 | |
| 127 | Research Site | Miskolc | Hungary | 3526 | |
| 128 | Research Site | Miskolc | Hungary | 3527 | |
| 129 | Research Site | Nagykanizsa | Hungary | 8800 | |
| 130 | Research Site | Nyiregyhaza | Hungary | 4400 | |
| 131 | Research Site | Pécs | Hungary | 7624 | |
| 132 | Research Site | Szekszárd | Hungary | 7100 | |
| 133 | Research Site | Szigetvár | Hungary | 7900 | |
| 134 | Research Site | Veszprém | Hungary | 8200 | |
| 135 | Research Site | Zalaegerszeg | Hungary | 8900 | |
| 136 | Research Site | Beer-Sheva | Israel | 84001 | |
| 137 | Research Site | Netanya | Israel | 4244916 | |
| 138 | Research Site | Roma | Italy | 00137 | |
| 139 | Research Site | Fukuyama-shi | Japan | 721-8511 | |
| 140 | Research Site | Kawasaki-shi | Japan | 210-0013 | |
| 141 | Research Site | Maebashi-shi | Japan | 371-0811 | |
| 142 | Research Site | Okayama-shi | Japan | 701-1192 | |
| 143 | Research Site | Osaka-shi | Japan | 556-0005 | |
| 144 | Research Site | Sapporo-shi | Japan | 062-0931 | |
| 145 | Research Site | Shizuoka-shi | Japan | 420-0005 | |
| 146 | Research Site | Yokosuka-shi | Japan | 238-8558 | |
| 147 | Research Site | Incheon | Korea, Republic of | 22332 | |
| 148 | Research Site | Seoul | Korea, Republic of | 03722 | |
| 149 | Research Site | Jekabpils | Latvia | LV-5201 | |
| 150 | Research Site | Riga | Latvia | 1004 | |
| 151 | Research Site | Riga | Latvia | LV1002 | |
| 152 | Research Site | Valmiera | Latvia | 4200 | |
| 153 | Research Site | Valmiera | Latvia | LV-4201 | |
| 154 | Research Site | Kaunas | Lithuania | 48259 | |
| 155 | Research Site | Kaunas | Lithuania | 50161 | |
| 156 | Research Site | Mexico | Mexico | 06720 | |
| 157 | Research Site | Christchurch | New Zealand | 8011 | |
| 158 | Research Site | Grafton | New Zealand | 1023 | |
| 159 | Research Site | Papatoetoe | New Zealand | 2025 | |
| 160 | Research Site | Wellington | New Zealand | 6021 | |
| 161 | Research Site | Chorrera | Panama | ||
| 162 | Research Site | Cuidad De Panama | Panama | ||
| 163 | Research Site | David | Panama | ||
| 164 | Research Site | Panama City | Panama | ||
| 165 | Research Site | Panama | Panama | ||
| 166 | Research Site | Krakow | Poland | 30-363 | |
| 167 | Research Site | Kraków | Poland | 30-348 | |
| 168 | Research Site | Leczna | Poland | 21-010 | |
| 169 | Research Site | Toruń | Poland | 87-100 | |
| 170 | Research Site | Wroclaw | Poland | 53-149 | |
| 171 | Research Site | Wrocław | Poland | 51-169 | |
| 172 | Research Site | Perm | Russian Federation | 614066 | |
| 173 | Research Site | Saint Petersburg | Russian Federation | 191025 | |
| 174 | Research Site | St Petersburg | Russian Federation | 193312 | |
| 175 | Research Site | St Petersburg | Russian Federation | 196084 | |
| 176 | Research Site | Cape Town | South Africa | 7505 | |
| 177 | Research Site | Cape Town | South Africa | 7530 | |
| 178 | Research Site | Cape Town | South Africa | 7800 | |
| 179 | Research Site | Durban | South Africa | 4091 | |
| 180 | Research Site | Johannesburg | South Africa | 2112 | |
| 181 | Research Site | Johannesburg | South Africa | 2193 | |
| 182 | Research Site | Pretoria | South Africa | 0087 | |
| 183 | Research Site | Pretoria | South Africa | 0101 | |
| 184 | Research Site | Rondebosch | South Africa | 7700 | |
| 185 | Research Site | Soweto | South Africa | 2013 | |
| 186 | Research Site | Alicante | Spain | 03010 | |
| 187 | Research Site | Antequera | Spain | 29200 | |
| 188 | Research Site | Castellon de la Plana | Spain | 12004 | |
| 189 | Research Site | Cordoba | Spain | 14004 | |
| 190 | Research Site | Granada | Spain | 18014 | |
| 191 | Research Site | La Laguna | Spain | 38320 | |
| 192 | Research Site | Leganes | Spain | 28911 | |
| 193 | Research Site | Lleida | Spain | 25198 | |
| 194 | Research Site | Madrid | Spain | 28040 | |
| 195 | Research Site | Malaga | Spain | 29004 | |
| 196 | Research Site | Mostoles | Spain | 28938 | |
| 197 | Research Site | Pozuelo de Alarcon | Spain | 28223 | |
| 198 | Research Site | San Juan de Alicante | Spain | 03550 | |
| 199 | Research Site | Sant Cugat del Valles | Spain | 08190 | |
| 200 | Research Site | Santiago de Compostela | Spain | 15706 | |
| 201 | Research Site | Tarragona | Spain | 43007 | |
| 202 | Research Site | Valencia | Spain | 46017 | |
| 203 | Research Site | Linköping | Sweden | 587 58 | |
| 204 | Research Site | Stockholm | Sweden | 118 83 | |
| 205 | Research Site | Adana | Turkey | 01330 | |
| 206 | Research Site | Ankara | Turkey | 06100 | |
| 207 | Research Site | Izmir | Turkey | 35100 | |
| 208 | Research Site | Kocaeli | Turkey | 41380 | |
| 209 | Research Site | Chernivtsі | Ukraine | 58001 | |
| 210 | Research Site | Dnipro | Ukraine | 49027 | |
| 211 | Research Site | Kyiv | Ukraine | 04050 | |
| 212 | Research Site | Sumy | Ukraine | 40022 | |
| 213 | Research Site | Vinnytsia | Ukraine | 21021 | |
| 214 | Research Site | Liverpool | United Kingdom | L12 2AP | |
| 215 | Research Site | London | United Kingdom | SW17 0RE |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT05238974
Other Study ID Numbers:
- D5290C00004
- NCT05238974
First Posted:
Jun 7, 2019
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Additional relevant MeSH terms: