A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
NCT ID: NCT02878330
Last Updated: 2019-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1453 participants
INTERVENTIONAL
2016-11-03
2018-12-06
Brief Summary
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A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
NCT02290340
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)
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A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
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Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Placebo
A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
MEDI8897 50 mg
Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
MEDI8897
A single IM dose of 50 mg on Day 1 of the study.
Interventions
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MEDI8897
A single IM dose of 50 mg on Day 1 of the study.
Placebo
A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Eligibility Criteria
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Inclusion Criteria
2. Infants who are entering their first full RSV season at the time of screening.
Exclusion Criteria
2. Any fever (\>= 100.4°F \[\>= 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization.
3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.
365 Days
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Anaheim, California, United States
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Anaheim, California, United States
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Downey, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Paramount, California, United States
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San Diego, California, United States
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West Covina, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Hartford, Connecticut, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Oak Lawn, Illinois, United States
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Park Ridge, Illinois, United States
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South Bend, Indiana, United States
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Woburn, Massachusetts, United States
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Detroit, Michigan, United States
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Jackson, Mississippi, United States
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Columbia, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Boone, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Gresham, Oregon, United States
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Erie, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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North Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Memphis, Tennessee, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
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Galveston, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Layton, Utah, United States
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Orem, Utah, United States
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Syracuse, Utah, United States
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Seattle, Washington, United States
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Huntington, West Virginia, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Bahía Blanca, , Argentina
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Guaymallen Mendoza, , Argentina
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Parkville, , Australia
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Subiaco, , Australia
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Ghent, , Belgium
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Mons, , Belgium
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Botucatu, , Brazil
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Campinas, , Brazil
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Canoas, , Brazil
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Curitiba, , Brazil
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Juiz de Fora, , Brazil
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Passo Fundo, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Montreal, Quebec, Canada
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Maipú, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Viña del Mar, , Chile
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Havlíčkův Brod, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Tampere, , Finland
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Turku, , Finland
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Bordeaux, , France
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Brest, , France
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Bron, , France
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Caen, , France
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Dijon, , France
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Tours, , France
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Nagykanizsa, , Hungary
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Nyireyghaza, , Hungary
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Sopron, , Hungary
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Szeged, , Hungary
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Szekszárd, , Hungary
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Veszprém, , Hungary
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Genova, , Italy
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Padua, , Italy
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Torino, , Italy
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Verona, , Italy
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Jēkabpils, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Christchurch, , New Zealand
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Otahuhu, , New Zealand
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Wellington, , New Zealand
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Łęczna, , Poland
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Cape Town, , South Africa
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Cape Town, , South Africa
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Claremont, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Pietermaritzburg, , South Africa
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Pretoria, , South Africa
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Alicante, , Spain
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Boadilla del Monte, , Spain
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Córdoba, , Spain
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Granada, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Sant Cugat del Vallès, , Spain
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Sant Joan d'Alacant, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Stockholm, , Sweden
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Stockholm, , Sweden
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Brighton, , United Kingdom
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Bristol, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Langer S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.
Ahani B, Tuffy KM, Aksyuk AA, Wilkins D, Abram ME, Dagan R, Domachowske JB, Guest JD, Ji H, Kushnir A, Leach A, Madhi SA, Mankad VS, Simoes EAF, Sparklin B, Speer SD, Stanley AM, Tabor DE, Hamren UW, Kelly EJ, Villafana T. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023 Jul 19;14(1):4347. doi: 10.1038/s41467-023-40057-8.
Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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D5290C00003\_Redacted\_protocol-amendment-1\_Red16JLU19
D5290C00003\_MEDI8897-Combined SAP\_PDFAv1.0
Other Identifiers
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D5290C00003
Identifier Type: -
Identifier Source: org_study_id
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