mRNA-1010 for Hay fever

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hay fever+1 More
mRNA-1010 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new vaccine can prevent seasonal influenza in adults aged 50 and over.

Eligible Conditions
  • Hay fever

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: 14 days post-vaccination through Day 181 or end of influenza season, whichever ends later

Day 181
Therapeutic radiology procedure
Time to First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Influenza A or B
Time to First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Influenza A or B
Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with Antigenically Matched to the Vaccine Strains
Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with Similarity to the Vaccine Strains
Time to First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Virus Strains
Time to First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Influenza A or B Virus Strains
Day 361
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Day 28
Number of Unsolicited Adverse Events (AEs)
Day 7
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Comparator TIV (6 to <72 Months)
18%Pyrexia
17%Upper respiratory tract infection
16%Diarrhea
14%Decreased appetite
13%Injection site pain
13%Irritability postvaccinal
12%Nasopharyngitis
10%Hypersomnia
8%Crying
7%Vomiting
7%Injection site erythema
6%Injection site hemorrhage
6%Gastroenteritis
5%Injection site induration
3%Injection site swelling
3%Headache
2%Fatigue
2%Myalgia
1%Pneumonia
1%Animal Bite
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01346592) in the Comparator TIV (6 to <72 Months) ARM group. Side effects include: Pyrexia with 18%, Upper respiratory tract infection with 17%, Diarrhea with 16%, Decreased appetite with 14%, Injection site pain with 13%.

Trial Design

2 Treatment Groups

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
1 of 2
mRNA-1010
1 of 2

Active Control

Experimental Treatment

23000 Total Participants · 2 Treatment Groups

Primary Treatment: mRNA-1010 · No Placebo Group · Phase 3

mRNA-1010
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: Biological
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Biological
ActiveComparator Group · 1 Intervention: Licensed quadrivalent inactivated seasonal influenza vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2021
Completed Phase 2
~890

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days post-vaccination through day 181 or end of influenza season, whichever ends later

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
65 Previous Clinical Trials
50,266,178 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and physically able to comply with follow-up procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas75.0%
North Carolina25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
PMG Research of Wilmington50.0%
Texas Center for Drug Development, Inc.50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
2100.0%
Why did patients apply to this trial?
  • "I have had a fever for as long as I can remember and most of the over-the-counter medicines don't have much. I would love to find something that actually worked"