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

NCT07208461 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infection Prevention

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

Sponsors & Collaborators

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yeqing Tong · Hubei Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208461 on ClinicalTrials.gov