Respiratory Syncytial Virus
Conditions
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
Brief summary
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.
Interventions
BIOLOGICALmRNA-1345
Suspension for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: * Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity. * Absence of serious or significant medical events within 30 days of Visit 1. * Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely. * Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment. Key
Exclusion criteria
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed. * Prior participation in research involving receipt of any investigational RSV product (drug/biologic). * Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study. Other protocol-specified inclusion and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Day 1 up to Day 7 (7 days post-injection) |
| Number of Participants with Unsolicited Adverse Events (AEs) | 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 | Day 1 up to Day 181 (End of study) |
| Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29 | Day 29 |
| GMT of Serum RSV-B Neutralizing Abs at Day 29 | Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| GMT of Serum RSV-A Neutralizing Abs | Day 1 up to Day 181 (End of study) |
| Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs | Day 181 |
| GMT of Serum RSV-B Neutralizing Abs | Day 1 up to Day 181 (End of study) |
| GMFR of Serum RSV-B Neutralizing Abs | Day 181 |
| Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs | Day 181 |
| Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs | Day 181 |
| Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers | Day 181 |
| Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers | Day 181 |
Countries
United States
Outcome results
None listed