NCT07418229

Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety of Different Doses of a Lyophilized RSV mRNA Vaccine in Adults Aged 18 Years and Older

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years

Detailed description

This is a randomized, double-blind, placebo-controlled clinical trial, enrolling a total of 60 participants aged ≥18 years. Eligible participants will be enrolled sequentially by age (18\~49 → ≥50 years old) and dosage (low → High), and then be randomized to the study group and the control group in a ratio of 2:1. Sentinel participant will be set. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events until 30 days after vaccination, as well as serious adverse events and adverse event of special interest throughout the whole study period.

Conditions

• RSV
• mRNA Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Low-dose RSV mRNA vaccine	One dose of RSV mRNA vaccine in low dosage
BIOLOGICAL	High-dose RSV mRNA vaccine	One dose of RSV mRNA vaccine in high dosage
OTHER	Placebo	Participants will receive one dose of normal saline.

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-06-30
• Completion: 2027-05-30
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China