Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.
This study is the fifth-year follow-up research for the previous clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated HAV vaccine | Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose |
| |
| Attenuated alive HAV vaccine | Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated HAV vaccine | Biological | Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination | to evaluate the immune persistence of anti-HAV antibodies in serum | 60 months after vaccination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Healthy Chinese children aged 18 to 35 months old
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Lun Zhang | Tianjin Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin center for disease prevention and control | Tianjin | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28319454 | Derived | Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum samples were taken from subjects.
| Attenuated alive HAV vaccine | Biological | Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose |
|
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |