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.
Age ≥40 years on enrollment day；
The informed consent of the subject can be obtained and signed；
The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
Armpit body temperature ≤37.0℃ on the day of enrollment.
People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
Do not use in persons with a history of allergic reaction to any of the components contained in this product；
Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
Parallel
Herpes Zoster Vaccine, Live
Biological/Vaccineassigned to the vaccine group and placebo group in a 2:1 ratio.
Placebo
Biological/Vaccineassigned to the vaccine group and placebo group in a 2:1 ratio.
Immunogenicity:
Geometric mean titer (GMT)at Day 0 and Day 42.
Immunogenicity:
geometric mean concentration (GMC) at Day 0 and Day 42.
Immunogenicity:
geometric mean fold increase (GMFI)at Day 0 and Day 42
Immunogenicity:
seroconversion/seroresponse rate (4-fold increase) at 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。
Click on the lead sponsor to view all of their trials.
Changchun BCHT Biotechnology Co.
Lead sponsor
Inner Mongolia Center for Disease Control and Prevention
Collaborator
Center for Disease Control and Prevention, Fujian
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
