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| Name | Class |
|---|---|
| Institute of Medical Biology, Chinese Academy of Medical Sciences | OTHER |
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The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attenuated Hepatitis A Vaccine, H2 Strain | Experimental | Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region. |
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| Inactivated Hepatitis A Vaccine, Lu8 Strain | Experimental | Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region. |
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| Group A Meningococcal Polysaccharide vaccine | Placebo Comparator | Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attenuated Hepatitis A Vaccine, H2 Strain | Biological | 6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of hepatitis A antibody concentration | Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination. | 37 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingsi Yang, PhD | Institude of Medical Biology, Chinese Academy of Medical Sciences | Study Chair |
| Fubao Ma | Jiangsu Province Centers for Disease Control and Prevention | Study Director |
| Qiangming Sun, PhD | Institude of Medical Biology, Chinese Academy of Medical Sciences | Principal Investigator |
| Guodong Kang | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China | ||
| Institute of Medical Biology -Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34222044 | Derived | Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 9, 2022 | |
| Reset | Jul 7, 2023 |
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| Inactivated Hepatitis A Vaccine, Lu8 Strain | Biological | 320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose |
|
| Group A Meningococcal Polysaccharide vaccine | Biological | 30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old |
|
| Kunming |
| Yunnan |
| 650118 |
| China |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 9, 2022 | Jul 7, 2023 |
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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