Hepatitis A, Hepatitis B
Conditions
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).
Interventions
BIOLOGICALInactivated Hepatitis A vaccine (HAV)
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
BIOLOGICALCombined hepatitis A and hepatitis B vaccine (HABV)
Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Post-immunization Seropositivity Rates (SPR) to Hepatitis A | 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
| Measure | Time frame | Description |
|---|---|---|
| The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV) | 7 months | 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) | 7 months | 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 | 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. |
| Occurrence of Adverse Events (AEs) | 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. |
Countries
China
Outcome results
None listed