NCT04612634

Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

A Randomized, Parallel Controlled Clinical Trial of the Safety and Immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried in Children Aged 18-24 Months Old

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

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.

Detailed description

To evaluate the safety and immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd, we design this randomized, parallel controlled study. 450 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (Research Group 1, 2, and 3), each group assigned 150 subjects respectively. All subjects are aged 18-24 months old. 150 subjects from Research Group 1 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later. 150 subjects from Research Group 2 will be administrated with one dose of Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later. 150 subjects from Research Group 3 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. Blood samples are collected before vaccination and one month (30 days) later. To evaluate the immunogenicity, we will detect and compare the seroconversion rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Conditions

• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun	Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
BIOLOGICAL	Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang	Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
BIOLOGICAL	Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS	Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-01-13
• Completion: 2021-07-01
• First posted: 2020-11-03
• Last updated: 2021-02-26

Locations

2 sites across 1 country: China