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The purpose of the sutdy is to evaluate the protective efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) (hereinafter referred to as "the investigational vaccine") in preventing herpes zoster at 13-36 months after complete immunization with the 0- and 2-month immunization schedule in individuals aged 40 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Group | Experimental | Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule |
|
| Placebo Group | Placebo Comparator | Subjects will receive NaCl solution placebo according to a 0, 2-month schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Zoster Vaccine (CHO Cell) | Biological | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection |
| Measure | Description | Time Frame |
|---|---|---|
| The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older, 13 to 36 months after completing the full vaccination course with the investigational vaccine according to the 0- and 2-month immunization schedule. | A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the Endpoint Adjudication Committee (EAC), consisting of physicians with HZ expertise. | At 13~36 months after the last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older: from 30 days to 36 months after completing the full vaccination course, and the annual person-year incidence from 30 days after the full vaccination. | At 30 days~36 months after the last vaccination. | |
| The person-year incidence rate of confirmed Herpes Zoster (HZ) cases during the periods of 30 days to 36 months, 13 to 36 months, and annually after 30 days post full-course immunization, in populations of different age groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Shijiazhuang | Hebei | 050021 | China | ||
| Henan Center for Diseases Control and Prevention |
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| NaCl solution Placebo | Biological | 0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection |
|
| 30 days to 36 months, 13 to 36 months, and 30 days after the last vaccination. |
| Incidence of any and severe Postherpetic Neuralgia (PHN) cases per person years in subjects aged 40 years and older, 40-49years , 50-59 years , 60-69 years and ≥70 years , with confirmed HZ. | 30 days after the last vaccination. |
| Zhengzhou |
| Henan |
| 450016 |
| China |
| Hubei Provincial Center for Disease Control and Prevention | Wuhan | Hubei | 430070 | China |
| Yunnan Center For Disease Control and Prevention | Kunming | Yunnan | 650022 | China |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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