drugset / Trial / NCT04612634
Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine
Phase 4
Unknown
450 enrolled
China National Biotec Group Company Limited
Changchun Institute of Biological Products Co., Ltd. · collabMianxian Center for Disease Control and Prevention · collabPeking University · collabShaanxi Provincial Center for Disease Control and Prevention · collabYangxian Center for Disease Control and Prevention · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Subjects will be recruited and divided into 3 groups: 1. Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd 2. Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and 3. Hepatitis A（Live）Vaccine，Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.
Timeline
- Start
- 2020-11-12
- Primary completion
- 2021-01-13
- Completion
- 2021-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun | Vaccine | 0.5 ml | — |
| Comparator | Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang | Vaccine | 0.5 ml | — |
| Comparator | Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS | Vaccine | 1 ml | — |
Indications
No indication recorded.