Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Months to 24 Months (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group 1
Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
Intervention: Hepatitis A Vaccine (Biological)
Group 2
Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited
Intervention: Hepatitis A Vaccine (Biological)
Outcomes
Primary Outcomes
To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
Time Frame: 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 Outcomes
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 month)