Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Overview

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.

Full Title of Study: “Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2017

Interventions

  • Biological: Hepatitis A Vaccine
    • Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
  • Active Comparator: Group 2
    • Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • China National Biotec Group Company Limited
  • Collaborator
    • Shaanxi Provincial Center for Disease Control and Prevention
  • Provider of Information About this Clinical Study
    • Sponsor

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