Hepatitis APhase 4NCT01252680
Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines
A Phase 4 study testing Healive+Healive, Healive+Havrix and Havrix+Havrix in people with Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated. Read more about this study
- Who is it for?
- Ages 18 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Healive+Healive, Healive+Havrix and Havrix+Havrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to May 2011
- 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 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
- Provided birth certification or vaccination card
- Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Who cannot join
- Axillary temperature > 37.0 centigrade at the time of dosing
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
Show all 12Show fewer
- History or family history of convulsions, epilepsy, brain disease and psychiatric
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Centers for Diseases Control and Prevention
Tianjin, Tianjin Municipality, 300011
About this study
Official title: A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children
This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.
Read the detailed description
This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.
- Conditions
- Hepatitis A
- Being tested
- Healive+Healive, Healive+Havrix, Havrix+Havrix, Havrix+Healive
- 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+HealiveBiological
Also called Hepatitis A vaccine
Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
Healive+HavrixBiological
Also called Hepatitis A vaccine
Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months
Havrix+HavrixBiological
Also called Hepatitis A vaccine
Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
Havrix+HealiveBiological
Also called Hepatitis A vaccine
Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Healive+Healive | Experimental | 75 subjects to receive two doses of Healive 6 months apart Receives: Biological: Healive+Healive |
| Group 2: Healive+Havrix | Experimental | 75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart Receives: Biological: Healive+Havrix |
| Group 3: Havrix+Havrix | Experimental | 75 subjects to receive two doses of Havrix 6 months apart Receives: Biological: Havrix+Havrix |
| Group 4: Havrix+Healive | Experimental | 75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart Receives: Biological: Havrix+Healive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
Measured: 7 months
Secondary outcomes (1)
safety of two inactivated hepatitis A vaccines
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionMay 2011
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 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 Centers for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252680
- Sponsor's protocol ID
- PRO-HA-4014
- Status last verified
- Mar 2013
- First submitted
- 29 Nov 2010
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang ZL, Zhu XJ, Wang X, Liang M, Sun J, Liu Y, Gao ZG, Wu JY, Dong XJ, Liu RK, Chen JT, Zhang YQ, Wang W, Zhang LP, Yin W. Interchangeability and tolerability of two inactivated hepatitis A vaccines in Chinese children. Vaccine. 2012 Jun 8;30(27):4028-33. doi: 10.1016/j.vaccine.2012.04.038. Epub 2012 Apr 23.
PubMed 22537990
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children
- ClinicalTrials.gov ID
- NCT01252680
- Acronym / sponsor ID
- PRO-HA-4014
- Conditions
- Hepatitis A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Dec 2010 (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.
This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.
Detailed description
This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healive+Healive | Experimental | Biological: Healive+Healive75 subjects to receive two doses of Healive 6 months apart |
| Group 2: Healive+Havrix | Experimental | Biological: Healive+Havrix75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart |
| Group 3: Havrix+Havrix | Experimental | Biological: Havrix+Havrix75 subjects to receive two doses of Havrix 6 months apart |
| Group 4: Havrix+Healive | Experimental | Biological: Havrix+Healive75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
- Provided birth certification or vaccination card
- Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Key exclusion criteria (12 listed)
- Axillary temperature > 37.0 centigrade at the time of dosing
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
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+HealiveAlso: Hepatitis A vaccineHepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart | Biological | Group 1: Healive+Healive |
| Healive+HavrixAlso: Hepatitis A vaccineTwo kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months | Biological | Group 2: Healive+Havrix |
| Havrix+HavrixAlso: Hepatitis A vaccineHepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart | Biological | Group 3: Havrix+Havrix |
| Havrix+HealiveAlso: Hepatitis A vaccineTwo kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months | Biological | Group 4: Havrix+Healive |
Primary outcome
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
Time frame: 7 months
1 secondary outcome
safety of two inactivated hepatitis A vaccines
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 15 Mar 2013.
- Derived from this study: PubMed 22537990Zhang ZL, Zhu XJ, Wang X, Liang M, Sun J, Liu Y, Gao ZG, Wu JY, Dong XJ, Liu RK, Chen JT, Zhang YQ, Wang W, Zhang LP, Yin W. Interchangeability and tolerability of two inactivated hepatitis A vaccines in Chinese children. Vaccine. 2012 Jun 8;30(27):4028-33. doi: 10.1016/j.vaccine.2012.04.038. Epub 2012 Apr 23.
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.
Zhi-lun Zhang principal investigator
Tianjin Centers 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+Healive, Healive+Havrix and Havrix+Havrix 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 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 15 Mar 2013. 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?
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines (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 NCT01252680, 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 15 Mar 2013.