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Virus Therapy
mRNA-1010 Vaccine for Flu
Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 121 and 181
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of 2 influenza vaccines against common flu strains.
Who is the study for?
This trial is for healthy adults who can become pregnant but are not currently, using contraception or abstaining from pregnancy-causing activities. They must have a BMI of 18-<40 kg/m^2 (Part A only), no acute illness/fever before vaccination, and no history of severe allergies to mRNA or flu vaccines.Check my eligibility
What is being tested?
The study tests the safety and immune response effectiveness of mRNA-1010 compared to other flu vaccines. Participants will be assessed on Day 29 for their body's defense against specific influenza strains.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at the injection site, fever, fatigue, headache, muscle pain. Severe allergic reactions are rare but possible in those with egg protein allergies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, days 121 and 181
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 121 and 181
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
+3 moreSecondary outcome measures
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
Side effects data
From 2022 Phase 1 & 2 trial • 885 Patients • NCT0495657591%
Injection site pain
80%
Fatigue
75%
Headache
70%
Chills
70%
Myalgia
61%
Arthralgia
50%
Injection site lymphadenopathy
39%
Vomiting
30%
Pyrexia
7%
COVID-19
5%
Urinary tract infection
5%
Anxiety
2%
Tendonitis
2%
Photosensitivity reaction
2%
Rash
2%
Subgaleal haematoma
2%
Spinal compression fracture
2%
Mouth injury
2%
Tooth fracture
2%
Panic attack
2%
Back pain
2%
Gastrointestinal bacterial infection
2%
Bipolar disorder
2%
Kidney contusion
2%
Arthropod bite
2%
Hypomagnesaemia
2%
Post-traumatic headache
2%
Concussion
2%
Traumatic liver injury
2%
Injection site erythema
2%
Fracture pain
2%
Migraine
2%
Urinary retention
2%
Influenza
2%
Tinnitus
2%
Injection site dermatitis
2%
Acute sinusitis
2%
Prostatic specific antigen increased
2%
Oropharyngeal pain
2%
Constipation
2%
Cartilage injury
2%
Lymphadenopathy
2%
Rib fracture
2%
Road traffic accident
2%
Hypothyroidism
2%
Injection site induration
2%
Cough
2%
Post-traumatic amnestic disorder
2%
Pelvic fracture
2%
Diarrhoea
2%
Skin laceration
2%
Substance abuse
2%
Lumbar vertebral fracture
2%
Upper respiratory tract infection
2%
Distributive shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1/2: mRNA-1010 200 ug
Phase 2 Extension: mRNA-1010 6.25 ug
Phase 2 NH: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 25 ug
Phase 2 Extension: mRNA-1010 12.5 ug
Phase 2 NH: mRNA-1010 100 ug
Phase 2 NH: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 50 ug
Phase 1/2: mRNA-1010 100 ug
Phase 2 NH: Afluria Quadrivalent 60 ug
Phase 2 Extension: Afluria Quadrivalent 60 ug
Phase 1/2: Placebo
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1010 (Age Group 65-80 years)Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.
Group II: mRNA-1010 (Age Group 18-50 years)Experimental Treatment1 Intervention
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Group III: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)Active Control1 Intervention
Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Group IV: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention
Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Group V: Inactivated Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention
Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2022
Completed Phase 3
~31590
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,815 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious allergic reaction in the past after getting an mRNA or flu vaccine, or any of the ingredients in those vaccines, like egg protein.I have used strong immune system suppressants for more than 2 weeks in the last 6 months.I am not pregnant, not breastfeeding, and will use birth control during and after the vaccine trial.I have not received immune-altering drugs or blood products in the last 90 days.You have a history of weak immune system or serious infections, unless certain immune conditions are well-managed and don't need strong medication.You have skin conditions like tattoos, psoriasis, or vitiligo on the area where the vaccine will be injected.In Part A of the study, your BMI needs to be between 18 and less than 40. There is no BMI requirement for Part B.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1010 (Age Group 65-80 years)
- Group 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
- Group 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
- Group 4: mRNA-1010 (Age Group 18-50 years)
- Group 5: Inactivated Influenza Vaccine (Age Group 65-80 years)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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