Status unknownNCT04612634Updated Feb 26, 2021

Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

A Phase 4 interventional study of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun and Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang in Vaccination, sponsored by China National Biotec Group Company Limited. Status unknown at 2 sites in China. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-26.

Sponsored by China National Biotec Group Company Limited · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 450
Allocation: Randomized
Ages: 18 Months to 24 Months
Sex: All

Study summary

Subjects will be recruited and divided into 3 groups:

Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd
Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and
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.

Read the 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.

Conditions studied

Vaccination

Browse trials for

Hepatitis A 2,709

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 450 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Months to 24 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

subjects aged from 18 to 24 months old at the date of recruitment;
with informed consent signed by parent(s) or guardians;
parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
subjects have not been vaccinated with any type of Hepatitis A vaccines;
subjects have no Hepatitis A disease and contraindication of vaccination;
subjects did not receive any vaccines within 14 days;
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

Exclusion Criteria:

Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history;
Allergic to any ingredient of vaccine or with allergy history to any vaccine;
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;
Receive non-specific immunoglobulin within 1 month before recruitment;
Subjects with acute febrile diseases with body temperature > 37.0 ℃ or infectious diseases;
Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection;
With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease;
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;
Various infectious, suppurative or allergic dermatitis;
Other circumstances judged by investigators that are not suitable for this clinical trial.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 450 participants (actual)

Study arms

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
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
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

Interventions

BiologicalHepatitis 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
BiologicalHepatitis 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.
BiologicalHepatitis 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 researchers measure

Primary outcomes

Antibody Seroconversion rate
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.
Time frame: 4 months

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04612634
Lead sponsor: China National Biotec Group Company Limited
Collaborators: Changchun Institute of Biological Products Co., Ltd., Shaanxi Provincial Center for Disease Control and Prevention, Mianxian Center for Disease Control and Prevention, Yangxian Center for Disease Control and Prevention, Peking University
Responsible party: Sponsor
First posted: Nov 3, 2020
Start date: Nov 12, 2020
Primary completion: Jan 13, 2021
Completion: Jul 2021 (estimated)
Last update: Feb 26, 2021

Study contacts

Shaobai Zhang

principal investigator · Shaanxi Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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