Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: Hepatitis A Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd | Biological: Hepatitis A Vaccine<br>* Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .<br>|
| Active Comparator: Group 2<br>Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited | Biological: Hepatitis A Vaccine<br>* Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |