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| Name | Class |
|---|---|
| Shanghai BravoBio Co., Ltd. | UNKNOWN |
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This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY | Experimental | Young adult subjects received low dose of BV211 |
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| HY | Experimental | Young adult subjects received high dose of BV211 |
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| Placebo | Placebo Comparator | Young adult subjects received placebo |
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| LO | Experimental | Old adult subjects received low dose of BV211 |
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| HO | Experimental | Old adult subjects received high dose of BV211 |
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| Control Vaccine | Active Comparator | Old adult subjects received control vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Zoster Vaccine | Biological | 0.5mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety in terms of adverse reactions/events | Incidence rates of adverse reactions/events (ADRs/AEs) | 30 mins, 0-7 days, 8-30 days and 0-30 days |
| Safety in terms of laboratory-based AEs | Incidence rates of abnormal laboratory indicators | 3 days after each vaccination |
| Safety in terms of SAEs | Incidence rates of SAEs | Within 6 months after full vaccination |
| Safety in terms of Adverse Events of Special Interest | Incidence rates of AESI | Within 6 months after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogencity in terms of GMT by ELISA or FAMA | GMC of anti-gE antibody and GMT of anti-VZV antibody | Days 1, 30, 60, 90 and 240 |
| Immunogencity in terms of Seroconversion Rates | Seroconversion rates of anti-gE and anti-VZV antibody responses |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Placebo | Biological | 0.5mL, Intramuscular |
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| Zoster Vaccine Recombinant, Adjuvanted | Biological | 0.5mL, Intramuscular |
|
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| Days 30, 60, 90 and 240 |
| Immunogencity in terms of Geometric Mean Fold Increase | GMFI of anti-gE and anti-VZV antibody responses | Days 30, 60, 90 and 240 |
| Immunogencity in terms of Cellular immunity | Frequency of CD4+ and CD8+T cells that express at least one cytokine | Days 1, 90 and 240 |
| D007239 | Infections |