Back to resultsComparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine
Primary Purpose
Hepatitis A, Hepatitis B
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated Hepatitis A vaccine (HAV)
Combined hepatitis A and hepatitis B vaccine (HABV)
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A
Eligibility 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;
Sites / Locations
- Hunan Provincial Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1 (HAV + HAV)
Group 2 (HAV + HABV)
Group 3 (HABV + HABV)
Arm Description
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;
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;
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;
Outcomes
Primary Outcome Measures
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
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
The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
The post-immunization GMC values of anti-HAV were measured using electrochemiluminescence immunoassay in serum samples collected at month 7.
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
The post-immunization GMC values of HBsAb were detected using electrochemiluminescence immunoassay in serum samples collected at month 7.
The Post-immunization SPR to Hepatitis B
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.
Occurrence of Adverse Events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02445703
Brief Title
Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A, Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (HAV + HAV)
Arm Type
Experimental
Arm Description
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;
Arm Title
Group 2 (HAV + HABV)
Arm Type
Experimental
Arm Description
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;
Arm Title
Group 3 (HABV + HABV)
Arm Type
Experimental
Arm Description
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;
Intervention Type
Biological
Intervention Name(s)
Inactivated Hepatitis A vaccine (HAV)
Other Intervention Name(s)
Healive (Sinovac Biotech Ltd.); lot No.: 201308046
Intervention Description
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
Intervention Type
Biological
Intervention Name(s)
Combined hepatitis A and hepatitis B vaccine (HABV)
Other Intervention Name(s)
Bilive (Sinovac Biotech Ltd.); lot No.: 201307017
Intervention Description
Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose
Primary Outcome Measure Information:
Title
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
Description
The post-immunization GMC values of anti-HAV were measured using electrochemiluminescence immunoassay in serum samples collected at month 7.
Time Frame
7 months
Title
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
Description
The post-immunization GMC values of HBsAb were detected using electrochemiluminescence immunoassay in serum samples collected at month 7.
Time Frame
7 months
Title
The Post-immunization SPR to Hepatitis B
Description
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.
Time Frame
7 months
Title
Occurrence of Adverse Events (AEs)
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangjun Li, BS
Organizational Affiliation
Hunan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincial Center for Disease Control and Prevention
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28060048
Citation
Li F, Hu Y, Zhou Y, Chen L, Xia W, Song Y, Tan Z, Gao L, Yang Z, Zeng G, Han X, Li J, Li J. A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine. Pediatr Infect Dis J. 2017 May;36(5):e157-e161. doi: 10.1097/INF.0000000000001535.
Results Reference
derived
Learn more about this trial
Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine
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