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Virus Therapy

RSV Vaccine + Fluzone HD for Respiratory Syncytial Virus

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

<p>Headlands Research, Inc. in Dublin, <a href="https://www.withpower.com/clinical-trials/california">California</a>; West Coast Research LLC in Riverside, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>; and Artemis Institute for Clinical Research in Rolling Hills Estates, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> are three of the 36 sites currently conducting this study.</p>

Velocity Clinical Research-Norfolk, Norfolk, NE

Fluzone HD +2 morePhase 3RecruitingResearch Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upday 22 (for arm 1) and day 43 (for arm 2)

Awards & highlights

Pivotal Trial

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.

Eligible Conditions

Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 22 (for arm 1) and day 43 (for arm 2)

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

101 Previous Clinical Trials

61,366,221 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

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.

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