A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
Key Inclusion Criteria:
Key Exclusion Criteria:
Washington D.C., District of Columbia 20016, United States
Topeka, Kansas 66604, United States
Lincoln, Nebraska 68504, United States
New Brunswick, New Jersey 08901, United States
Winston-Salem, North Carolina 27103, United States
Pittsburgh, Pennsylvania 15213, United States
Charlottesville, Virginia 22902, United States
Spokane, Washington 99202, United States
Huntington, West Virginia 25701, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1426BOS, Argentina
Mar de La Plata, Buenos Aires B7600FYH, Argentina
Brussels, Bruxelles-Capitale, Region de 1000, Belgium
Brussels, Bruxelles-Capitale, Region de 1200, Belgium
Pierrefonds, Quebec H9H 4Y6, Canada
Chongqing, Chongqing Municipality 400065, China
Guangzhou, Guangdong 510150, China
Dalian, Liaoning 116012, China
Medellín, Antioquia 050036, Colombia
Chía, Cundinamarca 250001, Colombia
Cali, Valle del Cauca Department 760001, Colombia
Aalborg, North Denmark 9000, Denmark
Tampere, Pirkanmaa 33100, Finland
Manila, National Capital Region 1000, Philippines
Quezon City, National Capital Region 1100, Philippines
Quezon City, National Capital Region 1118, Philippines
Poznan, Greater Poland Voivodeship 60-129, Poland
Tarnów, Lesser Poland Voivodeship 33-100, Poland
Trzebnica, Lower Silesian Voivodeship 55-100, Poland
Wroclaw, Lower Silesian Voivodeship 50-368, Poland
Mazowieckie, Masovian Voivodeship 02-972, Poland
Warsaw, Masovian Voivodeship 01-809, Poland
Cape Town, Western Cape 7700, South Africa
Bupyeong-gu, Incheon 21431, South Korea
Seongnam, Kyonggi-do 13620, South Korea
Dongjak-gu, Seoul 06973, South Korea
Muang, Changwat Khon Kaen 40002, Thailand
Hat Yai, Changwat Songkhla 90110, Thailand
London, London, City of SW17 0QT, United Kingdom
Oxford, Oxfordshire OX3 9DU, United Kingdom