Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines

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 Overview

• Status: Unknown
• Conditions: Hepatitis A
• Intervention / Treatment: Biological: Hepatitis A Vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Yuncheng, Shanxi, China
      • Shanxi Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Shaanxi Provincial Center for Disease Control and Prevention

Publications and helpful links

Helpful Links

• The reference 5
• The reference 6
• The reference 8
• The reference 9

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Anticipated): August 31, 2017
• Study Completion (Anticipated): December 29, 2017

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: 91110000100010062X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Based on the literature public progress.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No