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Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Sponsor: MAXVAX Biotechnology Limited Liability Company
Summary
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
Official title: A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
924
Start Date
2023-05-07
Completion Date
2026-03-31
Last Updated
2024-11-20
Healthy Volunteers
Yes
Conditions
Interventions
Low dose Recombinant Herpes Zoster Vaccine (CHO cells)
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
High dose Recombinant Herpes Zoster Vaccine (CHO cells)
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
Positive control
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride.
Locations (1)
Yanjin Center for Disease Control and Prevention
Xinxiang, Henan, China