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Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.

NCT07582796 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2026-05-27

No results posted yet for this study

Summary

The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted)

The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)

The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted)

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant)

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Normal Saline

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant)

The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.

Sponsors & Collaborators

  • Yither Biotech Co., Ltd

    collaborator UNKNOWN

  • Ab&B Bio-tech Co., Ltd.JS

    lead OTHER

Principal Investigators

  • Ting Huang, Bachelor · Sichuan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2027-09-14
Completion
2029-08-14

Countries

  • China

Study Locations

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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 NCT07582796 on ClinicalTrials.gov