Trials / Active Not Recruiting
Active Not RecruitingNCT05164094
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 867 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 10 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1189 | Sterile liquid for injection |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2021-12-28
- Primary completion
- 2026-10-05
- Completion
- 2026-10-05
- First posted
- 2021-12-20
- Last updated
- 2025-05-15
Locations
65 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05164094. Inclusion in this directory is not an endorsement.