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ACTIVE NOT RECRUITING
NCT06642558
PHASE1/PHASE2

Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.

Official title: A Phase I/II, Single Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

522

Start Date

2024-11-13

Completion Date

2027-02-28

Last Updated

2025-06-06

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

0.25 mL per dose.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

0.5 mL per dose

BIOLOGICAL

Placebo (Saline solution)

0.5 mL per dose

Locations (1)

Liangyuan District Center for Disease Prevention and Control

Shangqiu, Henan, China