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

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ClinicalTrials.gov Identifier: NCT02445703
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis A Hepatitis B Biological: Inactivated Hepatitis A vaccine (HAV) Biological: Combined hepatitis A and hepatitis B vaccine (HABV) Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445703


Locations
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China, Hunan
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Fangjun Li, BS Hunan Provincial Center for Disease Control and Prevention
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT02445703    
Other Study ID Numbers: PRO-HAB-4005
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: May 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs