NCT07272434

Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Aears and Above

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25,000 (estimated)
• Sponsor: MAXVAX Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.

Detailed description

A total of 25000 adults aged 60 years and above will be enrolled, stratified into 60-69 and ≥70 years of age. All Participants will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all Participants, while immunogenicity will be assessed in a subset of 1200 Participants in a selected trial site.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)	0.5 mL per dose
BIOLOGICAL	Placebo (Saline solution)	0.5 mL per dose

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-07-31
• Completion: 2028-12-31
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

8 sites across 1 country: China