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Virus Therapy

mRNA Vaccine for Flu Prevention

Q: To what extent could the mRNA NA vaccine pose risks to patients?

<p>mRNA NA <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a>'s safety is assessed at a level 1 due to the limited data available from Phase 1 trials, suggesting low levels of assurance in its efficacy and safety.</p>

Phase 1

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to day 366

Awards & highlights

Study Summary

This trial is testing a new vaccine for safety and how well it works. The study will give the vaccine to two groups of people, those aged 18-64 years and those aged 65 years and older, to see if it is safe and causes an immune response.

Who is the study for?

Adults aged 18+ who are healthy can join this trial. Women must not be pregnant/breastfeeding and use contraception if of childbearing potential. People with cancer, autoimmune diseases, severe allergies to vaccine ingredients, recent blood product recipients, high-dose steroid users within 6 months, or those with certain infections like HIV or hepatitis cannot participate.Check my eligibility

What is being tested?

The study is testing the safety and immune response to a new mRNA NA flu vaccine in adults. Participants will receive one dose by injection and will be split into two age groups: 18-64 years old and those 65+. It's compared against a high-dose quadrivalent influenza vaccine.See study design

What are the potential side effects?

As it's an early-phase trial for a flu shot, side effects might include pain at the injection site, fatigue, headache, muscle pain, feverish feelings but more specific side effects will be monitored given that it’s a new type of mRNA vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events of special interest

Number of participants with immediate adverse events

Number of participants with serious adverse events

+3 more

Secondary outcome measures

2-fold and 4-fold rise in NAI antibody titers

Individual Neuraminidase inhibition (NAI) titer

Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 3 mRNA NA: High dose levelExperimental Treatment1 Intervention

Participants will receive a high dose of mRNA vaccine

Group II: Group 2 mRNA NA: Medium dose levelExperimental Treatment1 Intervention

Participants will receive a medium dose of mRNA vaccine

Group III: Group 1 mRNA NA: Low dose LevelExperimental Treatment1 Intervention

Participants will receive a low dose of mRNA vaccine

Group IV: Group 4: QIV-HDActive Control1 Intervention

Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA NA vaccine

2022

Completed Phase 1

~240

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor

407 Previous Clinical Trials

6,091,748 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,019,066 Total Patients Enrolled

Media Library

mRNA NA vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05426174 — Phase 1

Healthy Subjects Research Study Groups: Group 2 mRNA NA: Medium dose level, Group 1 mRNA NA: Low dose Level, Group 3 mRNA NA: High dose level, Group 4: QIV-HD

Healthy Subjects Clinical Trial 2023: mRNA NA vaccine Highlights & Side Effects. Trial Name: NCT05426174 — Phase 1

mRNA NA vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426174 — Phase 1

Frequently Asked Questions

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

Are individuals currently being admitted to this clinical experiment?

"Correct. According to clinicaltrials.gov, this medical trial is still recruiting patients and was initially posted on June 16th 2022. It requires that 240 individuals from two sites take part in the study."

Answered by AI

What is the current enrollment size for this research project?

"Affirmative, the information on the clinicaltrials.gov website states that this medical trial is in active recruitment mode. Initially posted on June 16th 2022 and last amended September 30th 2022, it seeks to enrol 240 patients at 2 different sites."

Answered by AI

To what extent could the mRNA NA vaccine pose risks to patients?

"mRNA NA vaccine's safety is assessed at a level 1 due to the limited data available from Phase 1 trials, suggesting low levels of assurance in its efficacy and safety."

Answered by AI

What are the ultimate goals of this experiment?

"According to the data shared by Sanofi Pasteur, a subsidiary of Sanofi Company, the primary outcome being evaluated during this study is Number of participants with unsolicited adverse events; which will be monitored within 30 minutes after vaccination. Additionally, secondary metrics such as Individual Neuraminidase inhibition (NAI) titer expressed in GMTs at baseline and post-baseline intervals, Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29 also expressed in GMTs at both points in time, and 2-fold/4-fold rise in NAI antibody titers measured as percentual increases are"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

2022. "Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05426174.