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Cancer Vaccine

mRNA-1018 Vaccines for Flu

Phase 1 & 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 (day 1), days 22, 29, and 43

Awards & highlights

Study Summary

This trial tests the safety & effectiveness of 4 flu vaccine candidates with the hope of finding 1 to use in a larger trial.

Who is the study for?

Healthy adults over 18, with a BMI of 18-39 kg/m^2, can join this flu vaccine trial. Women must not be pregnant or breastfeeding and use birth control. You can't join if you're sick, have unstable health conditions, took certain drugs recently, got any vaccines in the last month, or are in another study.Check my eligibility

What is being tested?

The trial is testing mRNA-1018 vaccines for different flu strains (H5N8, H7N9, H5 only & H7 only) to see which is safest and works best. It's split into two parts: Part A tests four candidates; Part B focuses on one (H5 only-CG).See study design

What are the potential side effects?

Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue after vaccination. More details will be provided during the consent process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), days 22, 29, and 43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1), days 22, 29, and 43

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), days 22, 29, and 43 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 AEs Leading to Discontinuation From Study

Number of Participants with Adverse Events of Special Interest (AESIs)

Number of Participants with Medically-Attended AEs (MAAEs)

+3 more

Secondary outcome measures

GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay

GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay

Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay

+4 more

Trial Design

15Treatment groups

Experimental Treatment

Group I: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.

Group II: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.

Group III: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.

Group IV: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.

Group V: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.

Group VI: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.

Group VII: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.

Group VIII: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.

Group IX: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.

Group X: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.

Group XI: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.

Group XII: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.

Group XIII: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.

Group XIV: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.

Group XV: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1Experimental Treatment1 Intervention

Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.

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?

ModernaTX, Inc.Lead Sponsor

107 Previous Clinical Trials

61,376,621 Total Patients Enrolled

Media Library

mRNA-1018 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05972174 — Phase 1 & 2

Influenza Research Study Groups: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1, Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1, Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3, Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3, Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1, Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2, Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2, Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2, Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1, Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3, Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2, Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3, Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1, Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2, Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3

Influenza Clinical Trial 2023: mRNA-1018 Highlights & Side Effects. Trial Name: NCT05972174 — Phase 1 & 2

mRNA-1018 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05972174 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals have volunteered for this research endeavor?

"Correct. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking participants since its inception on July 10th 2023 and last update 25 days later. The research team needs to enroll 1500 people from one location for their study."

Answered by AI

Is enrollment still open for this investigation?

"Affirmative. According to records on clinicaltrials.gov, the study - which was introduced on July 10th 2023- is currently open for recruitment. 1 centre has been given the task of enrolling 1500 patients in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

2023. "A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972174.

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