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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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