A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.
The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.
In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.
In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.
Key Inclusion Criteria (Part A):
Key Inclusion Criteria (Part B):
Key Exclusion Criteria (Part A):
Key Exclusion Criteria (Part B):
Other inclusion and/or exclusion criteria may apply.
Phoenix, Arizona 85020, United States
Wheat Ridge, Colorado 80033, United States
St. Petersburg, Florida 33781, United States
Baton Rouge, Louisiana 70809, United States
New Orleans, Louisiana 70115, United States
Richfield, Minnesota 55423, United States
Creve Coeur, Missouri 63141, United States
Grand Island, Nebraska 68803, United States
Dakota Dunes, South Dakota 57049, United States
Fort Worth, Texas 76132, United States
Stephenville, Texas 76401, United States
Portsmouth, Virginia 23703, United States
Ciudad Autónoma de BuenosAires, 1426, Argentina
Ciudad Autónoma de BuenosAires, C1023, Argentina
Ciudad Autónoma de BuenosAires, C1425, Argentina
Ciudad Autónoma de BuenosAires, C1426ABP, Argentina
Zakiganj, Sylhet Division 3190, Bangladesh
Aguazul, Casanare Department 856010, Colombia
Bogota, Cundinamarca 110221, Colombia
Bogota, Cundinamarca 111611, Colombia
Girardot City, Cundinamarca 252431, Colombia
Ibague, Tolima Department 730001, Colombia
Hakata-ku, Fukuoka 812-0025, Japan
Naka-ku, Yokohama-ku, Kanagawa 231-0023, Japan
Chuo-ku, Tokyo 104-0031, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Shinjuku-ku, Tokyo 169-0072, Japan
Suginami-ku, Tokyo 168-0065, Japan
Toshima-ku, Tokyo 171-0014, Japan
Ciudad de Mexcio, Ciudad de Mexcio 03100, Mexico
Ciudad de Mexcio, Ciudad de Mexcio 06100, Mexico
Rotorua, Canterbury 3010, New Zealand
Poznan, Greater Poland Voivodeship 60-702, Poland
Wroclaw, Lower Silesian Voivodeship 50-381, Poland
Warsaw, Masovian Voivodeship 02-672, Poland
Gdansk, Pomeranian Voivodeship 80-382, Poland
Katowice, Silesian Voivodeship 40-040, Poland
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400, Poland
Somerset West, Western Cape 7130, South Africa
Jung-gu, Incheon 22332, South Korea
Gangnam-gu, Seoul 06351, South Korea