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

Condition(s) targeted: Hepatitis A; Hepatitis B

Intervention: Inactivated Hepatitis A vaccine (HAV) (Biological); Combined hepatitis A and hepatitis B vaccine (HABV) (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Sinovac Biotech Co., Ltd

Official(s) and/or principal investigator(s):
Fangjun Li, BS, Principal Investigator, Affiliation: Hunan Provincial Center for Disease Control and Prevention

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: The Post-immunization Seropositivity Rates (SPR) to Hepatitis A

Secondary outcome:

The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)

The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)

The Post-immunization SPR to Hepatitis B

Occurrence of Adverse Events (AEs)

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).

Minimum age: 18 Months. Maximum age: 24 Months. Gender(s): Both.

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;

- 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;

Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan 410005, China

Starting date: May 2014
Last updated: May 13, 2015