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mRNA-1010 (Age Group 18-50 years) for Influenza

Washington University in St. Louis, Saint Louis, MO
InfluenzamRNA-1010 - Biological
Eligibility
18 - 80
All Sexes

Study Summary

This trial will test the safety and effectiveness of 2 influenza vaccines against common flu strains.

Eligible Conditions
  • Influenza

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
Baloxavir
1
High Dose Quadrivalent Inactivated Influenza Vaccine
1
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

Study Objectives

6 Primary · 2 Secondary · Reporting Duration: Baseline, Days 121 and 181

Baseline, Day 29
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
Day 121
Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay
Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay
Day 181
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Day 29
Percentage of Participants with Seroresponse, as Measured by HAI Assay
Day 28
Number of Unsolicited Adverse Events (AEs)
Day 7
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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2
Baloxavir
2
High Dose Quadrivalent Inactivated Influenza Vaccine
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Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

Side Effects for

ATIV (6 to <72 Months)
27%Injection site pain
25%Pyrexia
14%Diarrhea
14%Upper respiratory tract infection
14%Decreased appetite
10%Injection site erythema
9%Irritability postvaccinal
9%Headache
9%Nasopharyngitis
8%Vomiting
8%Injection site induration
7%Injection site swelling
7%Fatigue
7%Myalgia
7%Hypersomnia
6%Crying
6%Injection site hemorrhage
4%Gastroenteritis
1%Pneumonia
1%Animal Bite
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01346592) in the ATIV (6 to <72 Months) ARM group. Side effects include: Injection site pain with 27%, Pyrexia with 25%, Diarrhea with 14%, Upper respiratory tract infection with 14%, Decreased appetite with 14%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

5 Treatment Groups

Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
1 of 5
Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
1 of 5
Inactivated Influenza Vaccine (Age Group 65-80 years)
1 of 5
mRNA-1010 (Age Group 18-50 years)
1 of 5
mRNA-1010 (Age Group 65-80 years)
1 of 5

Active Control

Experimental Treatment

125 Total Participants · 5 Treatment Groups

Primary Treatment: mRNA-1010 (Age Group 18-50 years) · No Placebo Group · Phase 2

mRNA-1010 (Age Group 18-50 years)
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: Biological
mRNA-1010 (Age Group 65-80 years)
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: Biological
Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
Biological
ActiveComparator Group · 1 Intervention: Egg-based Quadrivalent Influenza Vaccine · Intervention Types: Biological
Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
Biological
ActiveComparator Group · 1 Intervention: Adjuvanted Quadrivalent Influenza Vaccine · Intervention Types: Biological
Inactivated Influenza Vaccine (Age Group 65-80 years)
Biological
ActiveComparator Group · 1 Intervention: Inactivated Influenza Vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2022
Completed Phase 2
~2010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, days 121 and 181

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
80 Previous Clinical Trials
50,303,939 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Does this research offer a program for individuals above the age of thirty-five?

"This trail has an upper age limit of 80 and a lower threshold requiring the participant to be above legal adulthood." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this medical research?

"The scope of this medical investigation is targeting 125 individuals suffering from the flu, aged between 18 and 80. Notably, participants must have a body mass index (BMI) between 18 kg/m^2 to 40 kg/m^2 at screening. In addition, female patients of reproductive age are obligated to take a pregnancy test on day one; they need to practice safe contraception or abstain from sexual activities in the preceding 28 days prior to injection and until 3 months post-vaccination. Moreover, breastfeeding women may not participate in this trial." - Anonymous Online Contributor

Unverified Answer

How many participants are being enrolled in this research initiative?

"Affirmative. Data hosted on clinicaltrials.gov attests that this medical trial, originally made available on November 2nd 2022, is currently recruiting participants. 125 patients are being sought from a single location." - Anonymous Online Contributor

Unverified Answer

Are there remaining vacancies for this trial that individuals can apply to?

"As indicated on clinicaltrials.gov, this trial is actively recruiting patients with the original posting date being November 2nd 2022 and last edited on November 4th of that same year." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned mRNA-1010 for use in individuals aged 18 to 50?

"With the available evidence, our team at Power has cautiously assigned mRNA-1010 a safety rating of 2. This is due to Phase 2 data indicating there are some parameters around safety that have been established yet efficacy remains unconfirmed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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