Trials / Active Not Recruiting
Active Not RecruitingNCT06143046
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 0 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1345 | Sterile liquid for injection |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2023-11-15
- Primary completion
- 2026-05-27
- Completion
- 2026-05-27
- First posted
- 2023-11-22
- Last updated
- 2026-02-05
Locations
56 sites across 8 countries: United States, Canada, Chile, Denmark, Japan, Panama, South Africa, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06143046. Inclusion in this directory is not an endorsement.