Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.
Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attenuated HAV Vaccine, H2 Strain | Experimental | 6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-15 years \6.50 lgCCID50/ml in adults aged 16 up to 65 years old |
|
| Attenuated HAV Vaccine, L-A-1 Strain | Experimental | 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose). |
|
| Inactivated HAV Vaccine, Lu8 Strain | Experimental | 320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose |
|
| Inactivated HAV Vaccine, TZ84 Strain | Experimental | 250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attenuated HAV Vaccine, H2 Strain | Biological | 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose). |
| Measure | Description | Time Frame |
|---|---|---|
| changes of hepatitis A antibody concentration | 1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination. | up to 43 months |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of all the adverse events in vaccine group and placebo group | compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group. | up to 43 months |
Not provided
Inclusion Criteria:
Only subjects fulfilling all of the following criteria will be eligible for the study:
Exclusion Criteria:
Subjects will not be eligible for the study if any of the following criteria is met:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Qihan Li, Ph.D. | Institude of Medical Biology, Chinese Academy of Medical Sciences | Study Chair |
| Jingsi Yang | Institude of Medical Biology, Chinese Academy of Medical Sciences | Study Chair |
| Qiangming Sun, Ph.D. | Institude of Medical Biology, Chinese Academy of Medical Sciences | Principal Investigator |
| Fubao Ma | Jiangsu Province Centers for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Biology -Chinese Academy of Medical Sciences | Kunming | Yunnan | 650118 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Attenuated HAV Vaccine, L-A-1 Strain | Biological | 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose). |
|
|
| Inactivated HAV Vaccine, Lu8 Strain | Biological | 320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose |
|
|
| Inactivated HAV Vaccine, TZ84 Strain | Biological | 250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose. |
|
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| D014612 | Vaccines |
| D005612 | Freeze Drying |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015925 | Cryopreservation |
| D014021 | Tissue Preservation |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D011309 | Preservation, Biological |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided