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

Phase 4

Completed

• Conditions: Hepatitis B; Hepatitis A
• Interventions: Biological: Inactivated Hepatitis A vaccine (HAV); Biological: Combined hepatitis A and hepatitis B vaccine (HABV)

• Registration Number: NCT02445703
• Lead Sponsor: Sinovac Biotech Co., Ltd

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).

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-15
• Study Completion: 2016-06
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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;
• Administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;
• Body temperature > 37.0 °C before injection;
• Based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;

Exclusion Criteria of the Second Injection:

• Any acute infectious disease, body temperature > 38.5 °C or acute attacks of chronic diseases within 3 days prior to the second injection;
• Administration of blood product or other investigational drug during this study;
• Occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
• The investigator or the Ethic Committee decided that the subject should be excluded;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (HAV + HABV)	Inactivated Hepatitis A vaccine (HAV)	Intervention: Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 1 dose of inactivated HAV at day 0, and 1 dose of HABV at month 6. Route of administration: intramuscular injection in deltoid region;
Group 1 (HAV + HAV)	Inactivated Hepatitis A vaccine (HAV)	Intervention: Inactivated Hepatitis A vaccine (HAV); Subjects in this group each received 2 doses of inactivated HAV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region;
Group 2 (HAV + HABV)	Combined hepatitis A and hepatitis B vaccine (HABV)	Intervention: Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 1 dose of inactivated HAV at day 0, and 1 dose of HABV at month 6. Route of administration: intramuscular injection in deltoid region;
Group 3 (HABV + HABV)	Combined hepatitis A and hepatitis B vaccine (HABV)	Intervention: Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 2 doses of HABV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region;

Primary Outcome Measures

Name	Time	Method
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A	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 Outcome Measures

Name	Time	Method
The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)	7 months	The post-immunization GMC values of anti-HAV were measured using electrochemiluminescence immunoassay in serum samples collected at month 7.
The Post-immunization SPR to Hepatitis B	7 months	The post-immunization SPR is the percent of participants with HBsAb titer ≥ 10 mIU/mL at month 7. HBsAb titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
Occurrence of Adverse Events (AEs)	7 months	AE information was collected after first injection (day 0) until month 7. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). After each injection, a 30-minute safety observation was conducted immediately, and body temperature and solicited adverse events (AEs) within 72 hours were recorded. Unsolicited AEs information was collected from day 0 (after injection) to month 7.
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)	7 months	The post-immunization GMC values of HBsAb were detected using electrochemiluminescence immunoassay in serum samples collected at month 7.

Trial Locations

Locations (1)

Hunan Provincial Center for Disease Control and Prevention; 🇨🇳 Changsha, Hunan, China