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mRNA Vaccine
mRNA-1468 for Shingles
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
In general, do you consider yourself to be in good health?
Have you not ever been vaccinated against chickenpox or shingles?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 393 (month 14)
Awards & highlights
Study Summary
This trial will measure if a vaccine is safe and triggers an immune response in people.
Eligible Conditions
- Shingles
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Do you feel like you are healthy overall?
Select...
You have never received a vaccine for chickenpox or shingles.
Select...
You have not had shingles in the last 10 years.
Select...
Are you available and willing to attend up to 10 in-person visits and up to 8 phone calls over a period of about 15 months?
Select...
You must be 50 years old or above.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 393 (month 14)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 393 (month 14)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Number of Participants with Serious AEs, Medically Attended AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest
Number of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Titer
Geometric Mean Titer of Anti-glycoprotein E (gE)-specific Binding Antibodies (bAb) as Measured by Enzyme-linked Immunosorbent Assay
Vaccine Seroresponse Rate of Participants
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1468: Dose 4Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Group II: mRNA-1468: Dose 3Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Group III: mRNA-1468: Dose 2Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Group IV: mRNA-1468: Dose 1Experimental Treatment2 Interventions
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57.
Group V: ShingrixActive Control1 Intervention
Participants will receive Shingrix by IM injection on Day 1 and Day 57.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
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
108 Previous Clinical Trials
61,379,406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Do you feel like you are healthy overall?You have not had shingles in the last 10 years.Are you available and willing to attend up to 10 in-person visits and up to 8 phone calls over a period of about 15 months?You have never received a vaccine for chickenpox or shingles.You must be 50 years old or above.
Awards:
This trial has 0 awards, including: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.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1468: Dose 4
- Group 2: mRNA-1468: Dose 1
- Group 3: mRNA-1468: Dose 3
- Group 4: Shingrix
- Group 5: mRNA-1468: Dose 2
Shingles Patient Testimony for trial: Trial Name: NCT05701800 — Phase 1 & 2
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