NCT02445703

Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine

Phase IV Immunogenicity and Safety Study of Different Immunization Schedules of Inactivated Hepatitis A Vaccine (HAV) and/ or Combined Hepatitis A and Hepatitis B Vaccine (HABV) in Healthy Chinese Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants.

Detailed description

This study is a randomized double-blind, single-center, phase IV clinical trial. The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants between 18 and 24 months old. The subjects were randomly assigned into 3 groups. Subjects in group 1 each received 2 doses of HAV with a 6-month interval (at day 0 and month 6); subjects in group 2 each received 1 dose of HAV at day 0 and 1 dose of HABV at month 6; subjects in group 3 each received 2 doses of HABV with a 6-month interval (at day 0 and month 6).

Conditions

• Hepatitis A
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Hepatitis A vaccine (HAV)	Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
BIOLOGICAL	Combined hepatitis A and hepatitis B vaccine (HABV)	Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2016-06-01
• First posted: 2015-05-15
• Last updated: 2021-07-27

Locations

1 site across 1 country: China