Verified

mRNA-1468: Dose 2 for Shingles

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Floridian Clinical Research, Miami Lakes, FLShinglesmRNA-1468 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will measure if a vaccine is safe and triggers an immune response in people.

Eligible Conditions
  • Shingles

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Up to Day 393 (Month 14)

Month 6
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Titer
Month 1
Geometric Mean Titer of Anti-glycoprotein E (gE)-specific Binding Antibodies (bAb) as Measured by Enzyme-linked Immunosorbent Assay
Month 6
Vaccine Seroresponse Rate of Participants
Month 14
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
Day 64
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Day 85
Number of Participants with Unsolicited Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Shingrix
1 of 5
mRNA-1468: Dose 2
1 of 5
mRNA-1468: Dose 1
1 of 5
mRNA-1468: Dose 3
1 of 5
mRNA-1468: Dose 4
1 of 5

Active Control

Experimental Treatment

500 Total Participants · 5 Treatment Groups

Primary Treatment: mRNA-1468: Dose 2 · Has Placebo Group · Phase 1 & 2

mRNA-1468: Dose 2
Biological
Experimental Group · 1 Intervention: mRNA-1468 · Intervention Types: Biological
mRNA-1468: Dose 1Experimental Group · 2 Interventions: mRNA-1468, Placebo · Intervention Types: Biological, Biological
mRNA-1468: Dose 3
Biological
Experimental Group · 1 Intervention: mRNA-1468 · Intervention Types: Biological
mRNA-1468: Dose 4
Biological
Experimental Group · 1 Intervention: mRNA-1468 · Intervention Types: Biological
Shingrix
Biological
ActiveComparator Group · 1 Intervention: Shingrix · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 393 (month 14)

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,290,523 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Do you feel like you are healthy overall?
You have never received a vaccine for chickenpox or shingles.
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 must be 50 years old or above.

Who else is applying?

What state do they live in?
Louisiana84.2%
California15.8%
What portion of applicants met pre-screening criteria?
Met criteria47.4%
Did not meet criteria52.6%
Why did patients apply to this trial?
  • "I have had shingles,"
  • "Interested in medical trial research."
  • "I never know when they I will have a break out."
  • "To help me and other people I thought it might help"
  • "I don’t think I have ever had the shingles vaccine shot before"
What questions have other patients asked about this trial?
  • "How long do visits usually take?"
  • "The question asked about being a female of child bearing age ect…. I have had a total hysterectomy is that going to be an issue in being active in the trials if I’m chosen to participate?"
How many prior treatments have patients received?
075.0%
125.0%
What site did they apply to?
Research Works, INC100.0%

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email50.0%
Phone Call50.0%
Most responsive sites:
  1. Research Works, INC: < 24 hours

Frequently Asked Questions

Is it still possible to enroll in this clinical experiment?

"According to clinicaltrials.gov, this study is no longer accepting patients for participation as the trial was last updated on January 18th 2023. Despite this closure of recruitment, there are still 54 other trials that require participants at present time." - Anonymous Online Contributor

Unverified Answer

To what extent does this research venture take place in our state?

"19 clinical centres are presently recruiting patients for this medical trial, including Tekton Research, Inc - Longmont Center in Longmont, Meridien Research in Lakeland and Floridian Clinical Research in Miami Lakes. There are numerous other sites involved as well." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.