Study Summary
This trial is testing a new RSV vaccine to see if it is safe and effective.
Eligible Conditions
- Respiratory Syncytial Virus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 9 Secondary · Reporting Duration: Baseline and 1, 6, 12, 18, and 24 months postinjection
Month 12
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection
VE of mRNA-1345 to Prevent Hospitalizations Associated with RSV-ARD or RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) within the Period of 14 Days Postinjection up to 12 Months Postinjection
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms within the Period of 14 Days Postinjection up to 12 Months Postinjection
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms within the Period of 14 Days Postinjection up to 12 Months Postinjection
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection
Month 24
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
Month 24
Geometric Mean Concentration (GMC) of Serum RSV Binding Abs
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs)
Proportion of Participants with ≥4-fold Increases in Ab Titers from Baseline
Seroresponse Rate in RSV Neutralizing Abs
Month 24
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal up to 24 Months Postinjection
Day 28
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 Days Postinjection
Day 7
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) up to 7 Days Postinjection
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
mRNA-1345
1 of 2
Placebo
1 of 2
Experimental Treatment
37000 Total Participants · 2 Treatment Groups
Primary Treatment: mRNA-1345 · Has Placebo Group · Phase 2 & 3
mRNA-1345
Drug
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: DrugPlacebo
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 1, 6, 12, 18, and 24 months postinjection
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,254,020 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Adults eighty years or older who are self-reliant for their own care and activities of daily living are eligible for this study, as long as they meet the following criteria: they have not had a change in medication therapy within one month due to treatment failure or toxicity, they have not had a medical event qualifying as a Serious Adverse Event within one month of the planned study injection, and they do not have any known serious illnesses that would preclude them from completing the study.
You have a past or present history of heart failure or lung disease that affects breathing.
Have you ever had a bad reaction to a vaccine?
You do not have any immune system disorders or defects from birth.
Your body weight is within a healthy range, neither too low nor too high.
Who else is applying?
What state do they live in?
| Maryland | 41.2% |
| District of Columbia | 17.6% |
| Virginia | 11.8% |
| Other | 29.4% |
How old are they?
| 18 - 65 | 50.0% |
| 65+ | 50.0% |
What site did they apply to?
| Velocity Clinical Research, San Diego | 4.2% |
| Meridian Clinical Research- Rockville, MD | 4.2% |
| Washington Health Institute | 79.2% |
| Other | 12.5% |
What portion of applicants met pre-screening criteria?
| Met criteria | 12.1% |
| Did not meet criteria | 87.9% |
Why did patients apply to this trial?
- "I don't have"
- "Am new to the program"
- "I wish to advance medical science."
- "I am interested in doing any clinical trials I qualify for. I have participated in clinical trials before with PMG. I live in Wilmington"
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
Are there a significant number of hospitals participating in this trial within the state?
"74 patients are enrolled in this study with locations at the Washington Health Institute, Velocity Clinical Research, Valparaiso, Meridian Clinical Research, as well as 74 other sites." - Anonymous Online Contributor
Unverified Answer
Are we able to include new patients in this research project?
"This trial, which was first advertised on November 17th 2021, is still looking for participants. The December 23rd 2021 edit to the listing on clinicaltrials.gov was likely a typos." - Anonymous Online Contributor
Unverified Answer