Hepatitis ANCT02002065
The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children
An observational study of Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children. Read more about this study
- Who is it for?
- Ages 18 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Inactivated HAV vaccine and Attenuated alive HAV vaccine
- Type of treatment
- Vaccines
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Jun 2014
- Phase
- Observational
- 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy Chinese children aged 18 to 35 months old
Who may be able to join
- All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial
Who cannot join
- Subjects who refused to continue in the follow-up study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
Read the detailed description
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.
This study is the fifth-year follow-up research for the previous clinical trial.
- Conditions
- Hepatitis A
- Being tested
- Inactivated HAV vaccine, Attenuated alive HAV vaccine
- Keywords
- hepatitis A, inactivated hepatitis A vaccine, attenuated alive hepatitis A vaccine, immune persistence
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated HAV vaccineBiological
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Attenuated alive HAV vaccineBiological
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
| Study group | Role | What they receive |
|---|---|---|
| Inactivated HAV vaccine | Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose Receives: Biological: Inactivated HAV vaccine | |
| Attenuated alive HAV vaccine | Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose Receives: Biological: Attenuated alive HAV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
to evaluate the immune persistence of anti-HAV antibodies in serum
Measured: 60 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startOct 2008
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhi-Lun Zhang, Principal investigator, Tianjin Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002065
- Sponsor's protocol ID
- PRO-HA-4013 version 2.0
- Status last verified
- Apr 2016
- First submitted
- 28 Nov 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.
PubMed 28319454
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children
- ClinicalTrials.gov ID
- NCT02002065
- Acronym / sponsor ID
- PRO-HA-4013 version 2.0
- Conditions
- Hepatitis A
- Keywords
- hepatitis A, inactivated hepatitis A vaccine, attenuated alive hepatitis A vaccine, immune persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Dec 2013 (estimated)
- 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.
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
Detailed description
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.
This study is the fifth-year follow-up research for the previous clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactivated HAV vaccine | – | Biological: Inactivated HAV vaccineInactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose |
| Attenuated alive HAV vaccine | – | Biological: Attenuated alive HAV vaccineAttenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose |
Who may qualify
- Ages
- 18 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Chinese children aged 18 to 35 months old
Key inclusion criteria (1 listed)
- All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial
Key exclusion criteria (1 listed)
- Subjects who refused to continue in the follow-up study
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 |
|---|---|---|
| Inactivated HAV vaccineInactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose | Biological | Inactivated HAV vaccine |
| Attenuated alive HAV vaccineAttenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose | Biological | Attenuated alive HAV vaccine |
Primary outcome
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
Time frame: 60 months after vaccination
to evaluate the immune persistence of anti-HAV antibodies in serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 28319454Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.
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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.
Zhi-Lun Zhang principal investigator
Tianjin Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A, run by Sinovac Biotech Co., Ltd 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jul 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination (time frame: 60 months after vaccination). 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 NCT02002065, which also lists 1 linked publication.
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 14 Jul 2016.