A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
Phase 2
Completed
NCT05137236
| Condition | SARS-CoV-2 |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | ModernaTX, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 540 participants |
|---|
| Interventions | mRNA-1283, mRNA-1283.211, mRNA-1273, mRNA-1283.529 |
|---|
| Start date | Dec 6, 2021 |
|---|
| Completion date | Mar 23, 2023 |
|---|
| Results posted | Jul 17, 2025 |
|---|
Summary
The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.
Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 7 · Participants
| Part A: mRNA-1283 Low Dose | 30 Participants |
|---|
| Part A: mRNA-1283 Medium Dose | 40 Participants |
|---|
| Part A: mRNA-1283 High Dose | 37 Participants |
|---|
| Part A: mRNA-1283.211 Low Dose | 28 Participants |
|---|
| Part A: mRNA-1283.211 High Dose | 29 Participants |
|---|
| Part A: mRNA-1273 | 46 Participants |
|---|
Parts A and B: Number of Participants With Unsolicited AEs
Up to Day 28 · Participants
| Part A: mRNA-1283 Low Dose | 13 Participants |
|---|
| Part A: mRNA-1283 Medium Dose | 9 Participants |
|---|
| Part A: mRNA-1283 High Dose | 11 Participants |
|---|
| Part A: mRNA-1283.211 Low Dose | 12 Participants |
|---|
| Part A: mRNA-1283.211 High Dose | 7 Participants |
|---|
| Part A: mRNA-1273 | 8 Participants |
|---|
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
Day 1 to Day 366 · Participants
| Part A: mRNA-1283 Low Dose | 2 Participants |
|---|
| Part A: mRNA-1283 Medium Dose | 1 Participants |
|---|
| Part A: mRNA-1283 High Dose | 2 Participants |
|---|
| Part A: mRNA-1283.211 Low Dose | 3 Participants |
|---|
| Part A: mRNA-1283.211 High Dose | 3 Participants |
|---|
| Part A: mRNA-1273 | 2 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.