The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
507
Suspension for injection
Velocity Clinical Research, Denver
Denver, Colorado, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 up to Day 7 (7 days post-injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Time frame: Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
Time frame: Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
GMT of Serum RSV-A Neutralizing Abs
Time frame: Day 1 up to Day 181 (End of study)
Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs
Time frame: Day 181
GMT of Serum RSV-B Neutralizing Abs
Time frame: Day 1 up to Day 181 (End of study)
GMFR of Serum RSV-B Neutralizing Abs
Time frame: Day 181
Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs
Time frame: Day 181
Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs
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Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Velocity Clinical Research, Covington
Covington, Louisiana, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Velocity Clinical Research, Austin
Austin, Texas, United States
Velocity Clinical Research, Hampton
Hampton, Virginia, United States
...and 1 more locations
Time frame: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers
Time frame: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers
Time frame: Day 181