Hepatitis A
Conditions
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.
Interventions
BIOLOGICALHepatitis A Vaccine
Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
China National Biotec Group Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* 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℃
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed