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

July 26, 2021 updated by: Sinovac Biotech Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 (HAV + 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;
Biological: Inactivated Hepatitis A vaccine (HAV)
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
Other Names:
  • Healive (Sinovac Biotech Ltd.); lot No.: 201308046
EXPERIMENTAL: Group 2 (HAV + 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;
Biological: Inactivated Hepatitis A vaccine (HAV)
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
Other Names:
  • Healive (Sinovac Biotech Ltd.); lot No.: 201308046
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
Other Names:
  • Bilive (Sinovac Biotech Ltd.); lot No.: 201307017
EXPERIMENTAL: Group 3 (HABV + 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;
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
Other Names:
  • Bilive (Sinovac Biotech Ltd.); lot No.: 201307017

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
Time Frame: 7 months
The post-immunization GMC values of anti-HAV were measured using electrochemiluminescence immunoassay in serum samples collected at month 7.
7 months
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
Time Frame: 7 months
The post-immunization GMC values of HBsAb were detected using electrochemiluminescence immunoassay in serum samples collected at month 7.
7 months
The Post-immunization SPR to Hepatitis B
Time Frame: 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.
7 months
Occurrence of Adverse Events (AEs)
Time Frame: 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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Biotech Co., Ltd

Investigators

  • Principal Investigator: Fangjun Li, BS, Hunan Provincial Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (ESTIMATE)

May 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HAB-4005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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