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Virus Therapy

mRNA-1345 + Flu Vaccine for RSV

Phase 3
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 22 (for arm 1) and day 43 (for arm 2)
Awards & highlights

Study Summary

This trial will study the safety and immune response of adults over 65 when receiving a RSV vaccine and a high dose flu vaccine together.

Who is the study for?
This trial is for adults aged 65 or older who are medically stable, not of childbearing potential, and have no recent serious medical events. They must not have had close contact with flu or RSV patients recently, nor received any vaccines within a month before the study or plan to get one within a month after.Check my eligibility
What is being tested?
The study tests the safety and immune response of an RSV vaccine called mRNA-1345 when given with Fluzone HD (a high-dose flu vaccine) in seniors. It will check how each vaccine affects the body's defense against both RSV and four strains of influenza.See study design
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever, fatigue, headache, muscle pains similar to those experienced with other vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am postmenopausal or cannot become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 22 (for arm 1) and day 43 (for arm 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 22 (for arm 1) and day 43 (for arm 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs)
Number of Participants With AEs Leading to Discontinuation
+5 more
Secondary outcome measures
GMFR of Serum Ab Level, as Measured by HAI Assay
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs
Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Fluzone HD Followed by mRNA-1345Experimental Treatment3 Interventions
Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
Group II: Fluzone HD + mRNA-1345Experimental Treatment3 Interventions
Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluzone HD
2015
Completed Phase 4
~420
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,376,225 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential hazards associated with Fluzone HD + mRNA-1345 for patients?

"Fluzone HD + mRNA-1345 has been subject to multiple rounds of clinical testing, making it eligible for a rating of 3 on our scale that evaluates safety."

Answered by AI

Are there any US hospitals where this clinical experiment is being conducted?

"Headlands Research, Inc. in Dublin, California; West Coast Research LLC in Riverside, Florida; and Artemis Institute for Clinical Research in Rolling Hills Estates, Georgia are three of the 36 sites currently conducting this study."

Answered by AI

Does this research opportunity still have openings for participants?

"According to clinicaltrials.gov, this medical trial is not currently recruiting patients despite being initially posted on September 25th 2023 and edited as recently as September 23rd 2023. However, 104 other trials are seeking participants at the present moment."

Answered by AI

Who else is applying?

What site did they apply to?
Headlands Research, Inc.
Suncoast Research Associates, LLC
Delricht Tate
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I wanted to strengthen my body against RSV and flu. Aplico porque es bueno estar vacunado en contra de esa Condicion.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
2023. "A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060457.
All > Montreal > New Orleans
~237 spots leftby Jun 2024
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