Clinical trial NCT02445703: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Hepatitis B
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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;

Primary outcomes:
measure: The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
timeFrame: 7 months
Secondary outcomes:
measure: The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
timeFrame: 7 months
measure: The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
timeFrame: 7 months
measure: The Post-immunization SPR to Hepatitis B
timeFrame: 7 months
measure: Occurrence of Adverse Events (AEs)
timeFrame: 7 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial Center for Disease Control and Prevention
state: Hunan
Study officials:
affiliation: Hunan Provincial Center for Disease Control and Prevention
name: Fangjun Li, BS
role: PRINCIPAL_INVESTIGATOR
References:
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.