A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
Key Inclusion Criteria:
Extension substudy:
Key Exclusion Criteria:
Extension substudy:
North Hollywood, California 91606, United States
Washington D.C., District of Columbia 20011, United States
Binghamton, New York 13901-1046, United States
Fayetteville, North Carolina 28303, United States
League City, Texas 77573-1427, United States
Southbank, Queensland 4101, Australia
Hamburg, 20359, Germany
Beer Yaakov, Rishon Lezion 70300, Israel
Beer Sheva, Tel Aviv 8457108, Israel
Funabashi-shi, Chiba 274-0071, Japan
Osaka-shi Osaka, Kansai 530-0002, Japan
Habikino-shi, Osaka 583-8588, Japan
Sakai-shi, Osaka 593-8322, Japan
Kawagoe-shi, Saitama 350-1122, Japan
Chuo-ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 104-0031, Japan
Shibuya-ku, Tokyo 151-0051, Japan
Taito-ku, Tokyo 111-0036, Japan
Newcastle upon Tyne, Northumberland NE1 4LP, United Kingdom