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NOT YET RECRUITING
NCT07582796
PHASE1/PHASE2

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

Sponsor: Ab&B Bio-tech Co., Ltd.JS

View on ClinicalTrials.gov

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.

Official title: A Randomized, Blinded, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Adjuvanted) in Adults Aged 18 Years and Older.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

470

Start Date

2026-05-14

Completion Date

2029-08-14

Last Updated

2026-05-13

Healthy Volunteers

Yes

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.

Locations (1)

Zigong Center for Disease Control and Prevention

Zigong, Sichuan, China