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| Name | Class |
|---|---|
| Guangdong Provincial Institute of Biological Products And Materia Medica | OTHER |
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The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10μg/0.5ml recombinant HBV vaccine | Experimental | 5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10μg/0.5ml recombinant hepatitis B vaccine | Biological | 5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Within 30 days after hepatitis B vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 30th day after whole course of hepatitis B vaccination |
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Zhuhang, master | Contact | +86-020-36271871 | jade_lyy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Huizhen, master | Guangdong Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaozhou District Center for Disease Control and Prevention | Recruiting | Maoming | Guangdong | China |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D006509 | Hepatitis B |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. |
| The 1th year after whole course of hepatitis B vaccination |
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 2th year after whole course of hepatitis B vaccination |
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 3th year after whole course of hepatitis B vaccination |
| Xinxing District Center for Disease Control and Prevention | Recruiting | Yunfu | Guangdong | China |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D045424 |
| Complex Mixtures |