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ACTIVE NOT RECRUITING
NCT06447779
PHASE3

Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

Summary

The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.

Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of Recombinant Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25000

Start Date

2024-07-13

Completion Date

2027-09

Last Updated

2024-10-24

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Recombinant Zoster Vaccine (CHO Cell)

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection

BIOLOGICAL

NaCl solution Placebo

0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Locations (4)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Henan Center for Diseases Control and Prevention

Zhengzhou, Henan, China

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Yunnan Center For Disease Control and Prevention

Kunming, Yunnan, China