Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age

NCT05992935 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1403
  • BIOLOGICAL mRNA-1405

Study Locations (16)

Nebraska

  • Velocity Clinical Research — Norfolk
  • Velocity Clinical Research — Omaha

Other

  • Emeritus Research Camberwell — Camberwell
  • Nucleus Network — Melbourne

California

  • ARK Clinical Research, LLC — Long Beach

Colorado

  • Tekton Research, Inc - Longmont Center — Longmont

Florida

  • Research Centers of America — Hollywood

Georgia

  • Accel Research Sites Network — Decatur

Idaho

  • Velocity Clinical Research - Boise — Meridian

Illinois

  • Optimal Research — Peoria

Trial Details

FieldValue
Enrollment Target 1,405 participants
Start Date 2023-08-25
Est. Completion 2026-09-22
Phase Phase 1

Sponsor

ModernaTX

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05992935

The ClinicalTrials.gov registry entry for NCT05992935 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,405 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Norovirus Acute Gastroenteritis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05992935 reports 16 study locations spanning 14 distinct geographic areas — top geographies include Nebraska, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05992935 about?

NCT05992935 is a clinical study titled "Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age". The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactoge...

What is the current status of trial NCT05992935?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,405 participants. The study started on 2023-08-25. Estimated completion is 2026-09-22.

What conditions does trial NCT05992935 study?

This clinical trial studies the following conditions: Norovirus Acute Gastroenteritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05992935?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1403 (BIOLOGICAL), mRNA-1405 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05992935?

This trial is sponsored by ModernaTX, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05992935 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial