Comparative Immunogenicity Study of Two Hepatitis A Vaccines
- Conditions
- Hepatitis A
- Registration Number
- NCT03231605
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief Summary
Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.
- No Hepatitis A disease and contraindication of vaccination
- No history of Hepatitis A Vaccine
- The subjects can follow the requirements of experiment project.
- Do not vaccinate other vaccine in one months.
- Axillary's temperature≤37℃
- Having severe diseases.
- Allergy to the components in Vaccine
- Immune abnormalities
- The people who do not agree with the Inclusion Criteria
- Have a serious chronic disease
- Any conditions which researcher think will influence the results or the subjects.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. 35-42 days Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 1 month Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection.
Trial Locations
- Locations (1)
Shanxi Provincial Center for Disease Control and Prevention
🇨🇳Yuncheng, Shanxi, China
Shanxi Provincial Center for Disease Control and Prevention🇨🇳Yuncheng, Shanxi, China