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ACTIVE NOT RECRUITING
NCT07208461
PHASE2

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.

Official title: A Phase Ⅱ, Randomized, Observer-blinded, Placebo-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Older Adults Aged 60 Years and Older

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2025-10-21

Completion Date

2026-12

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Low dose antigen of LYB005 without A01B adjuvant

0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.

BIOLOGICAL

Low dose antigen of LYB005 with A01B adjuvant

0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.

BIOLOGICAL

Middle dose antigen of LYB005 without A01B adjuvant

0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.

BIOLOGICAL

Middle dose antigen of LYB005 with A01B adjuvant

0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.

BIOLOGICAL

High dose antigen of LYB005 without A01B adjuvant

0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.

BIOLOGICAL

High dose antigen of LYB005 with A01B adjuvant

0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.

BIOLOGICAL

Placebo

0.5 mL 0.9% sodium chloride (normal saline) injection per dose

Locations (1)

Center for Disease Control and Prevention of Dangyang City

Dangyang, China