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Virus Therapy
Modified mRNA Vaccines for Infectious Diseases
Phase 1
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 days 1 (baseline), 29, 85, and 197
Awards & highlights
Study Summary
This trial is testing how safe and effective a potential vaccine is.
Who is the study for?
Healthy adults aged 18-75 (18-50 for certain vaccines) with a BMI of 18 to 35 can join. They shouldn't plan to get other vaccines within a month of the study, have severe allergies to FLUAD's components, recent blood donations, or immunosuppressant use. Those who've had COVID-19 or flu shots recently are excluded.Check my eligibility
What is being tested?
The trial is testing modified mRNA vaccines targeting Flu, COVID-19, RSV and CMV. Vaccines like mRNA-1273 and others will be evaluated for safety and immune response in participants compared against FLUAD®, an approved influenza vaccine.See study design
What are the potential side effects?
Possible side effects may include pain at the injection site, fatigue, headache, muscle pain, chills and fever which are common reactions after vaccination. The severity varies from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 (baseline), 29, 85, and 197
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 (baseline), 29, 85, and 197
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 Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
+1 moreSecondary outcome measures
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647
Side effects data
From 2022 Phase 3 trial • 30415 Patients • NCT044704277%
Headache
7%
Fatigue
2%
Upper respiratory tract infection
2%
Injection site pain
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A (Blinded): Placebo
Part A (Blinded): mRNA-1273
Part B (Open-label): Placebo
Part B (Open-label): Placebo/mRNA-1273
Part B (Open-label): mRNA-1273
Part C: mRNA-1273 Booster
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: mRNA-1273Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1273 on Day 1
Group II: Part 2: mRNA-1010Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1010 on Day 1.
Group III: Part 1: mRNA-1647 3-DoseExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Group IV: Part 1: mRNA-1647 2-DoseExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Group V: Part 1: mRNA-1345Experimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Group VI: Part 2: FLUAD®Active Control1 Intervention
Participants will receive single IM injection of FLUAD® on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
mRNA-1010
2022
Completed Phase 3
~31590
mRNA-1647
2021
Completed Phase 2
~510
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,817 Total Patients Enrolled
37 Trials studying COVID-19
61,260,258 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old and in good health, or between 18 and under 50 for certain study arms.I had flu, RSV, or COVID-19 confirmed by a test recently.I have not taken drugs that weaken my immune system for more than 14 days in the last 6 months.I haven't been in a clinical study in the last 28 days and won't join another for 12 months after my last study vaccine.I have been vaccinated for flu, RSV, or CMV within the last 6 months, or haven't completed my COVID-19 vaccination series.Your body mass index (BMI) should be between 18 and 35.I plan to get a vaccine within 28 days of any study injection.I have been vaccinated for COVID-19 within the last 4 months or haven't completed the vaccine series.I have been in close contact with someone who had COVID-19, RSV, or the flu in the last 2 weeks.I am between 18 and 75 years old and in good health.I am between 18 and 49 years old and in good health.You had a bad allergic reaction to any part of the FLUAD vaccine or to any flu shot in the past.Your body mass index (BMI) is between 18 and 35.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: mRNA-1345
- Group 2: Part 1: mRNA-1647 2-Dose
- Group 3: Part 1: mRNA-1647 3-Dose
- Group 4: Part 2: mRNA-1273
- Group 5: Part 2: mRNA-1010
- Group 6: Part 2: FLUAD®
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How widely is this medical research being conducted across the city?
"Multiple trial sites are accepting enrolments, including Meridian Clinical Research in Lincoln, DM Clinical Research- Texas Center for Drug Development in Sioux City and Tekton Research Inc. located in Houston. Several other locations are also participating."
Answered by AI
Are participants aged 45 and over able to join this research project?
"Individuals that meet the age requirements of 18 years or more and 75 years or less are welcome to participate in this medical trial."
Answered by AI
Is it possible for me to participate in this research endeavor?
"To be eligible for this clinical trial, individuals must have been diagnosed with covid-19 and fall between 18 - 75 years old. 300 people are expected to join the study."
Answered by AI
Are there still openings in this investigation for participants?
"Affirmative, the information hosted on clinicaltrials.gov confirms that recruiting is underway for this medical trial which originally went live on May 24th 2022. The study has recently been updated and now requires 300 patients to be enrolled from 8 distinct sites."
Answered by AI
How many participants are actively participating in this experiment?
"To ensure a successful trial, 300 individuals must partake in the study and meet certain eligibility criteria. Multiple medical sites such as Meridian Clinical Research (Lincoln, Nebraska) or DM Clinical Research- Texas Center for Drug Development (Sioux City, Iowa) are available to recruit patients from."
Answered by AI
Has the FDA accepted mRNA-1273 for clinical use?
"Limited data backing the safety and efficacy of mRNA-1273 resulted in it receiving a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
Iowa
How old are they?
18 - 65
What site did they apply to?
Other
CenExel
Meridian Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've tested positive for COVID-19. Received email included this study.
PatientReceived no prior treatments
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