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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hepatitis A
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy infants between 18 and 24 months old;
- •Have not received hepatitis A vaccine before;
- •Completed hepatitis B vaccine full immunization schedule;
- •Written consent of the guardian of each participant;
- •Exclusion Criteria of the First Injection:
- •History of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
- •Autoimmune disease or immunodeficiency;
- •Any acute disease that made the conditions of the person unsuitable for vaccination
- •Administration of any live attenuated vaccine within 14 days prior to the injection;
- •Administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
Time Frame: 7 months
The post-immunization SPR is the percent of participants with anti-HAV titers ≥ 20 mIU/mL at month 7. Anti-HAV titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
Secondary Outcomes
- The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)(7 months)
- The Post-immunization SPR to Hepatitis B(7 months)
- Occurrence of Adverse Events (AEs)(7 months)
- The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)(7 months)