Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Phase 4

• Conditions: Hepatitis A
• Interventions: Biological: Hepatitis A Vaccine

• 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

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-24
• Study Start: 2017-07-26
• Study First Posted: 2017-07-27
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Hepatitis A Vaccine	Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
Group 2	Hepatitis A Vaccine	Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited

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