Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

February 24, 2021 updated by: China National Biotec Group Company Limited

A Randomized, Parallel Controlled Clinical Trial of the Safety and Immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried in Children Aged 18-24 Months Old

Subjects will be recruited and divided into 3 groups:

  1. Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd
  2. Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and
  3. Hepatitis A（Live）Vaccine，Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.

After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the safety and immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd, we design this randomized, parallel controlled study. 450 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (Research Group 1, 2, and 3), each group assigned 150 subjects respectively.

All subjects are aged 18-24 months old.

150 subjects from Research Group 1 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.

150 subjects from Research Group 2 will be administrated with one dose of Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.

150 subjects from Research Group 3 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. Blood samples are collected before vaccination and one month (30 days) later.

To evaluate the immunogenicity, we will detect and compare the seroconversion rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Hanzhong, Shaanxi, China, 723399
        • Yangxian Center for Disease Control and Prevention
      • Hanzhong, Shaanxi, China, 724200
        • Mianxian Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. subjects aged from 18 to 24 months old at the date of recruitment;
  2. with informed consent signed by parent(s) or guardians;
  3. parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
  4. subjects have not been vaccinated with any type of Hepatitis A vaccines;
  5. subjects have no Hepatitis A disease and contraindication of vaccination;
  6. subjects did not receive any vaccines within 14 days;
  7. before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be ≤37℃.

Exclusion Criteria:

  1. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history;
  2. Allergic to any ingredient of vaccine or with allergy history to any vaccine;
  3. Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases;
  4. Receive non-specific immunoglobulin within 1 month before recruitment;
  5. Subjects with acute febrile diseases with body temperature > 37.0 ℃ or infectious diseases;
  6. Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection;
  7. With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease;
  8. With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications;
  9. Various infectious, suppurative or allergic dermatitis;
  10. Other circumstances judged by investigators that are not suitable for this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Research Group 1
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
Active Comparator: Research Group 2
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
Active Comparator: Research Group 3
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. at the age of 18-24 months old, 1.0 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Seroconversion rate
Time Frame: 4 months
Blood samples were collected before and 30 (+ 10) days after immunization. Antibody level and antibody seroconversion rate of HAV-IgG will detect in laboratory. The antibody seroconversion rate of HAV-IgG must maintain the baseline as the other two comparators' products.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Geometric Mean Titer (GMT)
Time Frame: 4 months
Antibody GMT will detect in laboratory. The antibody GMT must maintain the baseline as the other two comparators' products.
4 months
Adverse Events Incidence rate
Time Frame: 6 months
Analyse the numbers and rates of participants who suffered from adverse events following immunization.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Biotec Group Company Limited

Collaborators

Peking University
Shaanxi Provincial Center for Disease Control and Prevention
Changchun Institute of Biological Products Co., Ltd.
Mianxian Center for Disease Control and Prevention
Yangxian Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Shaobai Zhang, Shaanxi Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Actual)

January 13, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 1, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGYM-2020-Ⅳ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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