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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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

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Hepatitis A Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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;

Group Type EXPERIMENTAL

Inactivated Hepatitis A vaccine (HAV)

Intervention Type BIOLOGICAL

Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.

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;

Group Type EXPERIMENTAL

Inactivated Hepatitis A vaccine (HAV)

Intervention Type BIOLOGICAL

Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.

Combined hepatitis A and hepatitis B vaccine (HABV)

Intervention Type BIOLOGICAL

Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose

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;

Group Type EXPERIMENTAL

Combined hepatitis A and hepatitis B vaccine (HABV)

Intervention Type BIOLOGICAL

Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose

Interventions

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Inactivated Hepatitis A vaccine (HAV)

Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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Healive (Sinovac Biotech Ltd.); lot No.: 201308046 Bilive (Sinovac Biotech Ltd.); lot No.: 201307017

Eligibility Criteria

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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

* 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;

* 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;

Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes