Hepatitis A Clinical Trial
Official title:
Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
Verified date | July 2017 |
Source | China National Biotec Group Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | December 29, 2017 |
Est. primary completion date | August 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 24 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanxi Provincial Center for Disease Control and Prevention | Yuncheng | Shanxi |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Shanxi Provincial Center for Disease Control and Prevention (China) |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. | 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. | 35-42 days | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. | 1 month |
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