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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 day 85 and day 225 (1 and 6 months after the last injection)
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 ~ day 85 and day 225 (1 and 6 months after the last injection)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85 and day 225 (1 and 6 months after the last injection)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Vaccine Seroresponse Rate of Participants
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: mRNA-1468: Dose 6Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Group II: Part 2: mRNA-1468: Dose 5Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Group III: Part 1: mRNA-1468: Dose 4Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Group IV: Part 1: mRNA-1468: Dose 3Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Group V: Part 1: mRNA-1468: Dose 2Experimental Treatment1 Intervention
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Group VI: Part 1: 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 in Part 1.
Group VII: Part 1: ShingrixActive Control1 Intervention
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.
Group VIII: Part 2: ShingrixActive Control1 Intervention
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.
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
118 Previous Clinical Trials
61,584,732 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: Part 1: mRNA-1468: Dose 1
- Group 2: Part 1: mRNA-1468: Dose 2
- Group 3: Part 1: mRNA-1468: Dose 3
- Group 4: Part 1: mRNA-1468: Dose 4
- Group 5: Part 1: Shingrix
- Group 6: Part 2: mRNA-1468: Dose 5
- Group 7: Part 2: mRNA-1468: Dose 6
- Group 8: Part 2: Shingrix
Shingles Patient Testimony for trial: Trial Name: NCT05701800 — Phase 1 & 2
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