A Multicenter, Randomized, Double-Blind, Placebo-Controll... | NCT06961721

Status Module

Name	Class
Inner Mongolia Center for Disease Control and Prevention	UNKNOWN
Center for Disease Control and Prevention, Fujian	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental vaccine：Herpes Zoster Vaccine, Live	Experimental	After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml.	Biological: Herpes Zoster Vaccine, Live
Identical to the test vaccine but without the varicella-zoster virus.	Placebo Comparator	After redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herpes Zoster Vaccine, Live	Biological	assigned to the vaccine group and placebo group in a 2:1 ratio.	Experimental vaccine：Herpes Zoster Vaccine, Live

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity:	Geometric mean titer (GMT)at Day 0 and Day 42.	Day 0 and Day 42
Immunogenicity:	geometric mean concentration (GMC) at Day 0 and Day 42.	Day 0 and Day 42
Immunogenicity:	geometric mean fold increase (GMFI)at Day 0 and Day 42	Day 0 and Day 42
Immunogenicity:	seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.	Day 0 and Day 42

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Incidence, severity, and causality of solicited local，systemic adverse events within 14 days post-vaccination； The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination； Incidence of Serious Adverse events (SAE) within 42 days after vaccination。	42 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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；
If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；
Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study；
Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；
Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；
Any situation that the investigator considers likely to affect the evaluation of the trial。

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D019433	Chickenpox Vaccine
D022283	Herpesvirus Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures