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The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zagreb2-1-1 | Experimental | Injection on day 0、7、21 |
|
| Essen | Active Comparator | Injection on day 0、3、7、14、28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zagreb2-1-1 | Biological | Injection on day 0、7、21 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Adverse Events of the rabies vaccine each injection | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titre of the subject on 0、7、14、42、180、365 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi | Beijing Chaoyang District Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Centers for Disease Control and Prevention | Zhaoqing | Guangdong | China | |||
| Wuhan Centers for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39358206 | Derived | Li L, Xu J, Zhang J, Wang F, Cai J, Yang L, Zhu Z, Bai Y, Jia B, Ma J, Shi N, Li S. Immunogenicity and immune persistence of Zagreb 2-1-1 regimen of rabies vaccine in Chinese healthy individuals: A randomized, parallel-controlled of homologous vaccine with different immune procedure study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2403177. doi: 10.1080/21645515.2024.2403177. Epub 2024 Oct 2. | |
| 28121231 |
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| Essen |
| Biological |
Injection on day 0、3、7、14、28 |
|
| Wuhan |
| Hubei |
| China |
| Beijing Chaoyang District Centers for Disease Control and Prevention | Beijing | China |
| Derived |
| Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25. |