Hepatitis APhase 3NCT01307436
Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines
A Phase 3 study testing Epaxal and Havrix 720 in people with Hepatitis A, run by Crucell Holland BV at 2 sites in Israel.
Trial summary
The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against… Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Epaxal and Havrix 720
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 2 sitesIsrael
- Study dates
- 14 Mar 2007to 8 Jul 2013
- Phase
- Phase 3
- 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 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Original study:
- Written informed consent obtained 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.
- At least 8 kg of body weight at age of 12 months.
- Follow-up phase:
- Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.
Who cannot join
- Original study:
- Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy
- Children having received a documented dose of MMR during infancy
- 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 the 30 days safety follow-up after the last dose.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of systemic corticosteroids (inhaled and topical steroids are allowed).
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- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- 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.
- Follow-up phase:
- Children who had received a hepatitis A antigen containing vaccine since the last visit
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal®) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.
The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
- Conditions
- Hepatitis A
- Being tested
- Epaxal, Havrix 720
- Keywords
- Hepatitis A Vaccine, Combined Vaccines, DTP Vaccine, MMR Vaccine
- Medical subject headings
- Hepatitis A, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpaxalBiological
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
Havrix 720Biological
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV Receives: Biological: Epaxal |
| Group B | Experimental | Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later Receives: Biological: Epaxal |
| Group C | Active comparator | Havrix 720 + concomitant administration of DTPaHibIPV, MMR Receives: Biological: Havrix 720 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Measured: 5.5 years
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Measured: 7.5 years
Secondary outcomes (2)
Geometric mean concentrations (GMC)
GMCs of anti-HAV antibodies
Measured: 5.5 and 7.5 years
Proportion of seroprotected subjects
Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml
Measured: 5.5 and 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study start14 Mar 2007
- Primary completion8 Jul 2013
- Study completion8 Jul 2013
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Dagan, MD, Principal investigator, Soraka Medical CenterShai Ashkenazi, MD, Principal investigator, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307436
- Sponsor's protocol ID
- CR106637
- Other IDs
- EPA 004 FU
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2011
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dagan R, Ashkenazi S, Livni G, Go O, Bagchi P, Sarnecki M. Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal Hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age. Pediatr Infect Dis J. 2016 Jul;35(7):e220-8. doi: 10.1097/INF.0000000000001176.
PubMed 27093164
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal®) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.
- ClinicalTrials.gov ID
- NCT01307436
- Acronym / sponsor ID
- CR106637
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A Vaccine, Combined Vaccines, DTP Vaccine, MMR Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2007 (actual)
- Primary completion
- 8 Jul 2013 (actual)
- Study completion
- 8 Jul 2013 (actual)
- First posted
- 3 Mar 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 this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: EpaxalEpaxal + concomitant administration of DTPaHibIPV, MMR, OPV |
| Group B | Experimental | Biological: EpaxalEpaxal, with administration of DTPaHibIPV, MMR, OPV one month later |
| Group C | Active comparator | Biological: Havrix 720Havrix 720 + concomitant administration of DTPaHibIPV, MMR |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written informed consent obtained 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.
- At least 8 kg of body weight at age of 12 months.
- Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.
Key exclusion criteria (14 listed)
- Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy
- Children having received a documented dose of MMR during infancy
- 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 the 30 days safety follow-up after the last dose.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of systemic corticosteroids (inhaled and topical steroids are allowed).
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 |
|---|---|---|
| Epaxal0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV) | Biological | Group A, Group B |
| Havrix 7200.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide | Biological | Group C |
Primary outcome
Anti-hepatitis A virus (HAV) antibody concentrations
Time frame: 5.5 years
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Anti-hepatitis A virus (HAV) antibody concentrations
Time frame: 7.5 years
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
2 secondary outcomes
Geometric mean concentrations (GMC)
Time frame: 5.5 and 7.5 years
Proportion of seroprotected subjects
Time frame: 5.5 and 7.5 years
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 8 Apr 2019.
- Results publication: PubMed 27093164Dagan R, Ashkenazi S, Livni G, Go O, Bagchi P, Sarnecki M. Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal Hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age. Pediatr Infect Dis J. 2016 Jul;35(7):e220-8. doi: 10.1097/INF.0000000000001176.
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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.
Ron Dagan, MD principal investigator
Soraka Medical Center
Shai Ashkenazi, MD principal investigator
Schneider Children's Medical Center, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epaxal and Havrix 720 in people with Hepatitis A, run by Crucell Holland BV at 2 sites in Israel.
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 6 inclusion and 14 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 8 Apr 2019. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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-hepatitis A virus (HAV) antibody concentrations (time frame: 5.5 years). The study lists 2 primary outcomes in all. 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 NCT01307436, 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 8 Apr 2019.