Hepatitis APhase 4NCT00534885
Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
A Phase 4 study testing Healive® Lot 1, Healive® Lot 2 and Healive® Lot 3 in people with Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®). Read more about this study
- Who is it for?
- Ages 12 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Healive® Lot 1, Healive® Lot 2 and Healive® Lot 3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Oct 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 12 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health children from 1 to 10 years
- Not participate in any other trial during the course of the trial
- Informed consent
Who cannot join
- Any history of allergic reactions or convulsions following vaccination
- Other known or planned vaccination within 1 month prior to the study and during the study period
- Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
- Presence of any congenital abnormality, upgrowth obstacle
- Any history/suspicion/presence of neurology and Lunacy
- Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
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- Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
- Abnormal ALT
- Positive markers for anti-HAV and HBV（HBsAg）infection
- Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.
Trial locations and contacts
1 site in 1 country.
China1 site
Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu, 213003
About this study
Official title: The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children
A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).
Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.
Read the detailed description
The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.
Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.
After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.
- Conditions
- Hepatitis A
- Being tested
- Healive® Lot 1, Healive® Lot 2, Healive® Lot 3, Havrix
- Keywords
- inactivated hepatitis A vaccine, Healive, safety, immunogenicity, 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.
Healive® Lot 1Biological
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Healive® Lot 2Biological
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
Healive® Lot 3Biological
Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
HavrixBiological
Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
| Study group | Role | What they receive |
|---|---|---|
| 1: Healive® Lot 1 | Experimental | Not described Receives: Biological: Healive® Lot 1 |
| 2: Healive® Lot 2 | Experimental | Not described Receives: Biological: Healive® Lot 2 |
| 3: Healive® Lot 3 | Experimental | Not described Receives: Biological: Healive® Lot 3 |
| 4: control vaccine (Havrix) | Active comparator | Not described Receives: Biological: Havrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HAV titer
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.
Measured: 7 months after the first dose
Secondary outcomes (3)
Solicited adverse reactions (AE): local reactions and systematic reactions
Solicited AEs were recorded until 72 hours after each injection
Measured: 72 hours after each injection
Unsolicited adverse reactions (AE)
Unsolicited AEs were recorded until month 7
Measured: 7 months after the first dose
Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate
Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66,112, 138 after the first dose to assess the change of long-term immune response. Anti-HAV antibodies were assessed by microparticle enzyme immunoassay (MEIA) assay (cut off: 20 mIU/ml)
Measured: baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startMar 2006
- Primary completionOct 2017
- Study completionOct 2017
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen-Yu Chen, Principal investigator, Changzhou City Centre for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534885
- Sponsor's protocol ID
- PRO-HA-4006
- Other IDs
- PRO-HA-4008 (11 Y follow-up)
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2007
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children
- ClinicalTrials.gov ID
- NCT00534885
- Acronym / sponsor ID
- PRO-HA-4006
- Conditions
- Hepatitis A
- Keywords
- inactivated hepatitis A vaccine, Healive, safety, immunogenicity, immune persistence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Sep 2007 (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.
A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).
Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.
Detailed description
The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.
Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.
After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Healive® Lot 1 | Experimental | Biological: Healive® Lot 1 |
| 2: Healive® Lot 2 | Experimental | Biological: Healive® Lot 2 |
| 3: Healive® Lot 3 | Experimental | Biological: Healive® Lot 3 |
| 4: control vaccine (Havrix) | Active comparator | Biological: Havrix |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Health children from 1 to 10 years
- Not participate in any other trial during the course of the trial
- Informed consent
Key exclusion criteria (10 listed)
- Any history of allergic reactions or convulsions following vaccination
- Other known or planned vaccination within 1 month prior to the study and during the study period
- Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
- Presence of any congenital abnormality, upgrowth obstacle
- Any history/suspicion/presence of neurology and Lunacy
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 |
|---|---|---|
| Healive® Lot 1Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart | Biological | 1: Healive® Lot 1 |
| Healive® Lot 2Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart | Biological | 2: Healive® Lot 2 |
| Healive® Lot 3Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart | Biological | 3: Healive® Lot 3 |
| HavrixInactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart | Biological | 4: control vaccine (Havrix) |
Primary outcome
Anti-HAV titer
Time frame: 7 months after the first dose
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.
3 secondary outcomes
Solicited adverse reactions (AE): local reactions and systematic reactions
Time frame: 72 hours after each injection
Unsolicited adverse reactions (AE)
Time frame: 7 months after the first dose
Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate
Time frame: baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose
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 4 Sep 2019.
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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.
Wen-Yu Chen principal investigator
Changzhou City Centre 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?
A Phase 4 study testing Healive® Lot 1, Healive® Lot 2 and Healive® Lot 3 in people with 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 3 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: finished, as of the sponsor's last update on 4 Sep 2019. 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?
Anti-HAV titer (time frame: 7 months after the first dose). 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 4 Sep 2019.