VaccinationPhase 4NCT04612634

Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

A Phase 4 study testing Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun, Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang and Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS in people with Vaccination, run by China National Biotec Group Company Limited at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Vaccination
What is being tested?: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun, Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang and Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 2 sitesChina
Study dates: 12 Nov 2020to Jul 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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℃.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

Other trials in China

About this study

Official title: 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:

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: Vaccination
Being tested: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun, Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang, Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hepatitis A (Live) Vaccine, Freeze-dried produced by ChangchunBiological
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
Hepatitis A (Live) Vaccine, Freeze-dried produced by ZhejiangBiological
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMSBiological
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.

Study groups in NCT04612634
Study group	Role	What they receive
Research Group 1	Experimental	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. Receives: Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun
Research Group 2	Active comparator	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. Receives: Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang
Research Group 3	Active comparator	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. Receives: Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 months

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 2020Jul 2021

First posted3 Nov 2020
Study start12 Nov 2020
Primary completion13 Jan 2021
Study completionJul 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for VaccinationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04612634
Sponsor's protocol ID: JGYM-2020-Ⅳ-01
Status last verified: Feb 2021
First submitted: 28 Oct 2020
Last updated: 26 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04612634
Acronym / sponsor ID: JGYM-2020-Ⅳ-01
Conditions: Vaccination
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 450 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
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
Study start: 12 Nov 2020 (actual)
Primary completion: 13 Jan 2021 (actual)
Study completion: Jul 2021 (estimated)
First posted: 3 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

All subjects are aged 18-24 months old.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Research Group 1	Experimental	Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun150 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 comparator	Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang150 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 comparator	Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS150 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.

Who may qualify

Ages: 18 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hepatitis A (Live) Vaccine, Freeze-dried produced by ChangchunAdministration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose	Biological	Research Group 1
Hepatitis A (Live) Vaccine, Freeze-dried produced by ZhejiangAdministration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.	Biological	Research Group 2
Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMSAdministration 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.	Biological	Research Group 3

Primary outcome

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.

2 secondary outcomes

Antibody Geometric Mean Titer (GMT)
Time frame: 4 months
Adverse Events Incidence rate
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 4
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shaobai Zhang principal investigator

Shaanxi Provincial Center for Disease Control and Prevention

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Seroconversion rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04612634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.