Comparative Immunogenicity Study of Two Hepatitis A Vaccines

China National Biotec Group (CNBG)

Status and phase: Unknown; Phase 4

Conditions: Hepatitis A

Treatments: Biological: Hepatitis A Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03231605

91110000100010062X

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Group 1

Experimental group

Description:

Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd

Treatment:

Biological: Hepatitis A Vaccine

Group 2

Active Comparator group

Description:

Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited

Treatment:

Biological: Hepatitis A Vaccine