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Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) |
|
| Placebo | Placebo Comparator | Placebo with no live virus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One shot of the varicella-zoster virus vaccine | Biological | One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of herpes zoster 30 days after vaccination. | The incidence of herpes zoster diagnosed in participants 30 days after vaccination. | 30 days-2 years after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of herpes zoster after vaccination. | The incidence of herpes zoster diagnosed in participants after vaccination. | within 0 day -2 years after the vaccination |
| The incidence of laboratory-confirmed herpes zoster 30 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Disease Control and Prevention | Loudi | Hunan | 417000 | China | ||
| Jiangsu Province Centers for Disease Control and Prevention |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| one shot of placebo | Biological | one shot of placebo with no live virus |
|
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination. |
| 30 days-2 years after the vaccination |
| The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination. | The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination. | 30 days-2 years after the vaccination |
| The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination. | The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after vaccination. | 30 days-2 years after the vaccination |
| The incidence of herpes zoster with severe pain (ZBPI scores≥3) 30 days after vaccination. Time Frame: 30 days-2 years after the vaccination | 30 days-2 years after the vaccination | The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination. |
| Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination. | Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination | 30 days after the vaccination |
| Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination. | geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination | 6 months after the vaccination |
| Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination. | geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination | 12 months after the vaccination |
| Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination. | geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination | 24 months after the vaccination |
| Occurrence of solicited adverse reactions after the vaccination. | Occurrence of solicited adverse reactions within 14 days after the vaccination. | within 14 days after the vaccination |
| Occurrence of adverse reactions after the vaccination. | Occurrence of adverse reactions within 30 days after the vaccination. | within 30 days after the vaccination |
| Occurrence of severe adverse reactions after the vaccination. | Occurrence of severe adverse reactions within 2 years after the vaccination. | within 2 years |
| Nanjing |
| Jiangsu |
| 210009 |
| China |
| Zhejiang Provincial Center for Disease Control and Prevention | Hanzhou | Zhejiang | 310051 | China |
| D007239 | Infections |