Hepatitis APhase 2NCT01405677
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
A Phase 2 study testing Epaxal 0.25 mL, Epaxal 0.5 mL and Havrix Junior 0.5 mL in people with Hepatitis A, run by Crucell Holland BV at 2 sites in Belgium.
Trial summary
The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. Read more about this study
- Who is it for?
- Ages 12 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Epaxal 0.25 mL, Epaxal 0.5 mL and Havrix Junior 0.5 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 2 sitesBelgium
- Study dates
- Jun 2004to Apr 2012
- Phase
- Phase 2
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Original study:
- Males or females aged >=12 months and 16 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - Free of obvious health problems as established by medical history and/or clinical examination before entering the study.
- Follow up phase:
- Subjects enrolled and randomized in the primary study and having received two doses of the study vaccine
Who cannot join
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this means prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids were allowed.)
- Planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine
- Previous vaccination against hepatitis A
- Seropositive for anti-HAV antibodies (>=10 mIU/mL)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Show all 9Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness
- Acute disease at the time of enrolment
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Sint-Vincentiusziekenhuis
Antwerp, B-2018
Centre for the Evaluation of Vaccination, University of Antwerp
Antwerp, BE-2610
About this study
Official title: A Phase II Open, Randomised, Controlled Study to Evaluate the Safety and Immunogenicity of a Paediatric Dose (0.25 mL) and the Standard Dose (0.5 mL) of Epaxal® With Reference to Havrix Junior® Healthy in Healthy Children and Adolescents (>=12 Months - 16 Years of Age) Using a 0/6 Month Schedule
The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).
- Conditions
- Hepatitis A
- Being tested
- Epaxal 0.25 mL, Epaxal 0.5 mL, Havrix Junior 0.5 mL
- Keywords
- Hepatitis A, Vaccination, Immunisation
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epaxal 0.25 mLBiological
12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
Epaxal 0.5 mLBiological
24 IU hepatitis A antigen coupled to IRIV
Havrix Junior 0.5 mLBiological
720 EU hepatitis A antigen absorbed onto aluminum hydroxide
| Study group | Role | What they receive |
|---|---|---|
| Epaxal 0.25 mL | Experimental | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 Receives: Biological: Epaxal 0.25 mL |
| Epaxal 0.5 mL | Active comparator | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 Receives: Biological: Epaxal 0.5 mL |
| Havrix Junior | Active comparator | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 Receives: Biological: Havrix Junior 0.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual anti-HAV titers
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Measured: 66 months post-booster
Individual anti-HAV titers
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Measured: 18 months post-booster
Individual anti-HAV titers
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Measured: 30 months post-booster
Individual anti-HAV titers
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Measured: 42 months post-booster
Individual anti-HAV titers
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Measured: 54 months post-booster
Secondary outcomes (2)
Geometric mean titers
Measured: 18, 30, 42, 54, 66 months post-booster
Seroprotection
Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL
Measured: 18, 30, 42, 54, 66 months post-booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJun 2004
- Primary completionApr 2012
- Study completionApr 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre van Damme, MD, Principal investigator, Universiteit AntwerpenAndre Vertruyen, MD, Principal investigator, Sint-Vincentiusziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405677
- Sponsor's protocol ID
- EPA 001 FU
- Status last verified
- Dec 2013
- First submitted
- 28 Jul 2011
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open, Randomised, Controlled Study to Evaluate the Safety and Immunogenicity of a Paediatric Dose (0.25 mL) and the Standard Dose (0.5 mL) of Epaxal® With Reference to Havrix Junior® Healthy in Healthy Children and Adolescents (>=12 Months - 16 Years of Age) Using a 0/6 Month Schedule
- ClinicalTrials.gov ID
- NCT01405677
- Acronym / sponsor ID
- EPA 001 FU
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A, Vaccination, Immunisation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Jul 2011 (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 primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epaxal 0.25 mL | Experimental | Biological: Epaxal 0.25 mLSingle intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
| Epaxal 0.5 mL | Active comparator | Biological: Epaxal 0.5 mLSingle intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
| Havrix Junior | Active comparator | Biological: Havrix Junior 0.5 mLSingle intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
Who may qualify
- Ages
- 12 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females aged >=12 months and 16 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - Free of obvious health problems as established by medical history and/or clinical examination before entering the study.
- Subjects enrolled and randomized in the primary study and having received two doses of the study vaccine
Key exclusion criteria (9 listed)
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this means prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids were allowed.)
- Planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine
- Previous vaccination against hepatitis A
- Seropositive for anti-HAV antibodies (>=10 mIU/mL)
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 |
|---|---|---|
| Epaxal 0.25 mL12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV) | Biological | Epaxal 0.25 mL |
| Epaxal 0.5 mL24 IU hepatitis A antigen coupled to IRIV | Biological | Epaxal 0.5 mL |
| Havrix Junior 0.5 mL720 EU hepatitis A antigen absorbed onto aluminum hydroxide | Biological | Havrix Junior |
Primary outcome
Individual anti-HAV titers
Time frame: 66 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Individual anti-HAV titers
Time frame: 18 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Individual anti-HAV titers
Time frame: 30 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Individual anti-HAV titers
Time frame: 42 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Individual anti-HAV titers
Time frame: 54 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
2 secondary outcomes
Geometric mean titers
Time frame: 18, 30, 42, 54, 66 months post-booster
Seroprotection
Time frame: 18, 30, 42, 54, 66 months post-booster
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 29 Jul 2014.
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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.
Pierre van Damme, MD principal investigator
Universiteit Antwerpen
Andre Vertruyen, MD principal investigator
Sint-Vincentiusziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epaxal 0.25 mL, Epaxal 0.5 mL and Havrix Junior 0.5 mL in people with Hepatitis A, run by Crucell Holland BV at 2 sites in Belgium.
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 5 inclusion and 9 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Individual anti-HAV titers (time frame: 66 months post-booster). The study lists 5 primary outcomes in all. 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 29 Jul 2014.