Hepatitis APhase 4NCT02445703

Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine

A Phase 4 study testing Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV) in people with Hepatitis A and Hepatitis B, run by Sinovac Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants. 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, Hepatitis B
What is being tested?: Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 1 siteChina
Study dates: May 2014to Jun 2016
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

Healthy infants between 18 and 24 months old;
Have not received hepatitis A vaccine before;
Completed hepatitis B vaccine full immunization schedule;
Written consent of the guardian of each participant;

Who cannot join

History of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
Autoimmune disease or immunodeficiency;
Any acute disease that made the conditions of the person unsuitable for vaccination
Administration of any live attenuated vaccine within 14 days prior to the injection;
Administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
Administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;

Show all 12Show fewer

Body temperature > 37.0 °C before injection;
Based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;
Any acute infectious disease, body temperature > 38.5 °C or acute attacks of chronic diseases within 3 days prior to the second injection;
Administration of blood product or other investigational drug during this study;
Occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
The investigator or the Ethic Committee decided that the subject should be excluded;

Trial locations and contacts

1 site in 1 country.

China1 site

Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005

Other trials in China

About this study

Official title: Phase IV Immunogenicity and Safety Study of Different Immunization Schedules of Inactivated Hepatitis A Vaccine (HAV) and/ or Combined Hepatitis A and Hepatitis B Vaccine (HABV) in Healthy Chinese Infants

Read the detailed description

This study is a randomized double-blind, single-center, phase IV clinical trial. The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants between 18 and 24 months old. The subjects were randomly assigned into 3 groups. Subjects in group 1 each received 2 doses of HAV with a 6-month interval (at day 0 and month 6); subjects in group 2 each received 1 dose of HAV at day 0 and 1 dose of HABV at month 6; subjects in group 3 each received 2 doses of HABV with a 6-month interval (at day 0 and month 6).

Conditions: Hepatitis A, Hepatitis B
Being tested: Inactivated Hepatitis A vaccine (HAV), Combined hepatitis A and hepatitis B vaccine (HABV)
Medical subject headings: Hepatitis A, Hepatitis B

What participants receive

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

Inactivated Hepatitis A vaccine (HAV)Biological
Also called Healive (Sinovac Biotech Ltd.); lot No.: 201308046
Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
Combined hepatitis A and hepatitis B vaccine (HABV)Biological
Also called Bilive (Sinovac Biotech Ltd.); lot No.: 201307017
Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose

Study groups in NCT02445703
Study group	Role	What they receive
Group 1 (HAV + HAV)	Experimental	Intervention: Inactivated Hepatitis A vaccine (HAV); Subjects in this group each received 2 doses of inactivated HAV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region; Receives: Biological: Inactivated Hepatitis A vaccine (HAV)
Group 2 (HAV + HABV)	Experimental	Intervention: Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 1 dose of inactivated HAV at day 0, and 1 dose of HABV at month 6. Route of administration: intramuscular injection in deltoid region; Receives: Biological: Inactivated Hepatitis A vaccine (HAV); Biological: Combined hepatitis A and hepatitis B vaccine (HABV)
Group 3 (HABV + HABV)	Experimental	Intervention: Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 2 doses of HABV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region; Receives: Biological: Combined hepatitis A and hepatitis B vaccine (HABV)

What is being measured

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

The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
The post-immunization SPR is the percent of participants with anti-HAV titers ≥ 20 mIU/mL at month 7. Anti-HAV titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
Measured: 7 months

Secondary outcomes (4)

The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
The post-immunization GMC values of anti-HAV were measured using electrochemiluminescence immunoassay in serum samples collected at month 7.
Measured: 7 months
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
The post-immunization GMC values of HBsAb were detected using electrochemiluminescence immunoassay in serum samples collected at month 7.
Measured: 7 months
The Post-immunization SPR to Hepatitis B
The post-immunization SPR is the percent of participants with HBsAb titer ≥ 10 mIU/mL at month 7. HBsAb titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
Measured: 7 months
Occurrence of Adverse Events (AEs)
AE information was collected after first injection (day 0) until month 7. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). After each injection, a 30-minute safety observation was conducted immediately, and body temperature and solicited adverse events (AEs) within 72 hours were recorded. Unsolicited AEs information was collected from day 0 (after injection) to month 7.
Measured: 7 months

Timeline

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

May 2014Jun 2016

First posted15 May 2015 (estimated)
Study startMay 2014
Primary completionJan 2015
Study completionJun 2016

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.
More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
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, Investigator
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445703
Sponsor's protocol ID: PRO-HAB-4005
Status last verified: May 2015
First submitted: 13 May 2015
Last updated: 27 Jul 2021
Results posted: No
Data monitoring committee: No

Publications

Li F, Hu Y, Zhou Y, Chen L, Xia W, Song Y, Tan Z, Gao L, Yang Z, Zeng G, Han X, Li J, Li J. A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine. Pediatr Infect Dis J. 2017 May;36(5):e157-e161. doi: 10.1097/INF.0000000000001535.
PubMed 28060048

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?

See locations

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

All Hepatitis A trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Immunogenicity and Safety Study of Different Immunization Schedules of Inactivated Hepatitis A Vaccine (HAV) and/ or Combined Hepatitis A and Hepatitis B Vaccine (HABV) in Healthy Chinese Infants
ClinicalTrials.gov ID: NCT02445703
Acronym / sponsor ID: PRO-HAB-4005
Conditions: Hepatitis A, Hepatitis B
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: Jan 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 15 May 2015 (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.

Detailed description

Study design

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

Arm	Type	Receives
Group 1 (HAV + HAV)	Experimental	Biological: Inactivated Hepatitis A vaccine (HAV)Intervention: Inactivated Hepatitis A vaccine (HAV); Subjects in this group each received 2 doses of inactivated HAV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region;
Group 2 (HAV + HABV)	Experimental	Biological: Inactivated Hepatitis A vaccine (HAV), Biological: Combined hepatitis A and hepatitis B vaccine (HABV)Intervention: Inactivated Hepatitis A vaccine (HAV) and Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 1 dose of inactivated HAV at day 0, and 1 dose of HABV at month 6. Route of administration: intramuscular injection in deltoid region;
Group 3 (HABV + HABV)	Experimental	Biological: Combined hepatitis A and hepatitis B vaccine (HABV)Intervention: Combined hepatitis A and hepatitis B vaccine (HABV); Subjects in this group each received 2 doses of HABV with a 6-month interval (day 0, month 6); Route of administration: intramuscular injection in deltoid region;

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy infants between 18 and 24 months old;
Have not received hepatitis A vaccine before;
Completed hepatitis B vaccine full immunization schedule;
Written consent of the guardian of each participant;

Key exclusion criteria (12 listed)

History of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
Autoimmune disease or immunodeficiency;
Any acute disease that made the conditions of the person unsuitable for vaccination
Administration of any live attenuated vaccine within 14 days prior to the injection;
Administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;

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 Hepatitis A vaccine (HAV)Also: Healive (Sinovac Biotech Ltd.); lot No.: 201308046Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.	Biological	Group 1 (HAV + HAV), Group 2 (HAV + HABV)
Combined hepatitis A and hepatitis B vaccine (HABV)Also: Bilive (Sinovac Biotech Ltd.); lot No.: 201307017Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose	Biological	Group 2 (HAV + HABV), Group 3 (HABV + HABV)

Primary outcome

The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
Time frame: 7 months
The post-immunization SPR is the percent of participants with anti-HAV titers ≥ 20 mIU/mL at month 7. Anti-HAV titers were detected in participants' serum samples using electrochemiluminescence immunoassay.

4 secondary outcomes

The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)
Time frame: 7 months
The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)
Time frame: 7 months
The Post-immunization SPR to Hepatitis B
Time frame: 7 months
Occurrence of Adverse Events (AEs)
Time frame: 7 months

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 27 Jul 2021.
Derived from this study: PubMed 28060048Li F, Hu Y, Zhou Y, Chen L, Xia W, Song Y, Tan Z, Gao L, Yang Z, Zeng G, Han X, Li J, Li J. A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine. Pediatr Infect Dis J. 2017 May;36(5):e157-e161. doi: 10.1097/INF.0000000000001535.

Related trials for Hepatitis A

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

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.

Fangjun Li, BS principal investigator

Hunan Provincial Center for Disease Control and Prevention

1 site 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 4 inclusion and 12 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 27 Jul 2021. 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?

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 Post-immunization Seropositivity Rates (SPR) to Hepatitis A (time frame: 7 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 NCT02445703, 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 27 Jul 2021.