Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine
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
1 other identifier
interventional
450
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFebruary 26, 2021
February 1, 2021
2 months
October 28, 2020
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (2)
Antibody Geometric Mean Titer (GMT)
4 months
Adverse Events Incidence rate
6 months
Study Arms (3)
Research Group 1
EXPERIMENTAL150 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.
Research Group 2
ACTIVE COMPARATOR150 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.
Research Group 3
ACTIVE COMPARATOR150 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.
Interventions
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
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.
Eligibility Criteria
You may qualify if:
- 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℃.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Biotec Group Company Limitedlead
- Changchun Institute of Biological Products Co., Ltd.collaborator
- Shaanxi Provincial Center for Disease Control and Preventioncollaborator
- Mianxian Center for Disease Control and Preventioncollaborator
- Yangxian Center for Disease Control and Preventioncollaborator
- Peking Universitycollaborator
Study Sites (2)
Yangxian Center for Disease Control and Prevention
Hanzhong, Shaanxi, 723399, China
Mianxian Center for Disease Control and Prevention
Hanzhong, Shaanxi, 724200, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaobai Zhang
Shaanxi Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
November 12, 2020
Primary Completion
January 13, 2021
Study Completion
July 1, 2021
Last Updated
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share