To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine. To evaluate the safety of the live attenuated herpes zoster vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
assigned to the vaccine group and placebo group in a 2:1 ratio.
assigned to the vaccine group and placebo group in a 2:1 ratio.
Immunogenicity:
Geometric mean titer (GMT)at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Immunogenicity:
geometric mean concentration (GMC) at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Immunogenicity:
geometric mean fold increase (GMFI)at Day 0 and Day 42
Time frame: Day 0 and Day 42
Immunogenicity:
seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Adverse Events
1. Incidence, severity, and causality of solicited local,systemic adverse events within 14 days post-vaccination; 2. The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination; 3. Incidence of Serious Adverse events (SAE) within 42 days after vaccination。
Time frame: 42 days
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