Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine
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
1 other identifier
interventional
301
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 27, 2021
May 1, 2015
8 months
May 13, 2015
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
7 months
Secondary Outcomes (4)
The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
7 months
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
7 months
The Post-immunization SPR to Hepatitis B
7 months
Occurrence of Adverse Events (AEs)
7 months
Study Arms (3)
Group 1 (HAV + HAV)
EXPERIMENTALIntervention: 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 2 (HAV + HABV)
EXPERIMENTALIntervention: 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 3 (HABV + HABV)
EXPERIMENTALIntervention: 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;
Interventions
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005, China
Related Publications (1)
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.
PMID: 28060048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fangjun Li, BS
Hunan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 15, 2015
Study Start
May 1, 2014
Primary Completion
January 1, 2015
Study Completion
June 1, 2016
Last Updated
July 27, 2021
Record last verified: 2015-05