Hepatitis APhase 4NCT03231605
Comparative Immunogenicity Study of Two Hepatitis A Vaccines
A Phase 4 study testing Hepatitis A Vaccine in people with Hepatitis A, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Hepatitis A Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2017to 29 Dec 2017
- 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
- 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℃
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanxi Provincial Center for Disease Control and Prevention
Yuncheng, Shanxi
About this study
Official title: 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.
- Conditions
- Hepatitis A
- Being tested
- Hepatitis A Vaccine
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A VaccineBiological
Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd Receives: Biological: Hepatitis A Vaccine |
| Group 2 | Active comparator | Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited Receives: Biological: Hepatitis A Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35-42 days
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start26 Jul 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion29 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaanxi Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231605
- Sponsor's protocol ID
- 91110000100010062X
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Based on the literature public progress.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
- ClinicalTrials.gov ID
- NCT03231605
- Acronym / sponsor ID
- 91110000100010062X
- Conditions
- Hepatitis A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Shaanxi Provincial Center for Disease Control and Prevention
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 29 Dec 2017 (estimated)
- First posted
- 27 Jul 2017 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Hepatitis A VaccineGroup 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd |
| Group 2 | Active comparator | Biological: Hepatitis A VaccineGroup 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 VaccineVaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result . | Biological | Group 1, Group 2 |
Primary outcome
To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
Time frame: 35-42 days
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.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- The reference 6Link provided by the sponsor.
- The reference 7Link provided by the sponsor.
- The reference 8Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Based on the literature public progress.
Related trials for Hepatitis A
Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Vaccine Reaction
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepatitis A Vaccine in people with Hepatitis A, run by China National Biotec Group Company Limited at 1 site in China.
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 6 inclusion and 6 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. (time frame: 35-42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2017.