Virus DiseasesPhase 3NCT02012998
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
A Phase 3 study testing HBVAXPRO 5µg in people with Virus Diseases and Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 10 sites in Italy.
Trial summary
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, Hepatitis B
- What is being tested?
- HBVAXPRO 5µg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 10 sitesItaly
- Study dates
- Jan 2014to Feb 2015
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy child
- Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
- Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose
Who cannot join
- Receipt of more than 3 doses of any Hepatitis B containing vaccine
- History of clinical diagnosis of infection due to Hepatitis B
- History or current close contact with known carriers of Hepatitis B virus
- Prior known sensitivity or allergy to any component of HBVAXPRO
- Chronic illness / medical condition that could interfere with study conduct or completion
- Coagulation disorder that would contraindicate intramuscular injection
Show all 10Show fewer
- Subject is pregnant
- Receipt of corticosteroids for more than 14 days in the 30 days prior to study
- Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
- Planned participation in another clinical study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Sanofi Pasteur MSD Investigational Site 004
Bologna
Sanofi Pasteur MSD Investigational Site 009
Cagliari
Sanofi Pasteur MSD Investigational Site 005
Capannori
Sanofi Pasteur MSD Investigational Site 003
Chiavari
Sanofi Pasteur MSD Investigational Site 002
Latisana
Sanofi Pasteur MSD Investigational Site 008
Massafra
Sanofi Pasteur MSD Investigational Site 006
Nocera Inferiore
Sanofi Pasteur MSD Investigational Site 010
Ragusa
Sanofi Pasteur MSD Investigational Site 007
Salerno
Sanofi Pasteur MSD Investigational Site 001
Sassari
About this study
Official title: An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
- Conditions
- Virus Diseases, Hepatitis B
- Being tested
- HBVAXPRO 5µg
- Medical subject headings
- Virus Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBVAXPRO 5µgBiological
Also called Hepatitis B vaccine (rDNA)
0.5mL intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| HBVAXPRO Challenge dose | Experimental | HBVAXPRO 5µg Receives: Biological: HBVAXPRO 5µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Measured: One month after the challenge dose
Secondary outcomes (4)
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Measured: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia
Measured: Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Measured: Day 0 to day 14 after vaccination
Serious adverse events
Measured: From signature of the informed consent to the last visit of the subject, an expected average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 Virus DiseasesStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012998
- Sponsor's protocol ID
- HXV02C
- Other IDs
- 2013-001602-28
- Status last verified
- Sep 2017
- First submitted
- 11 Dec 2013
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zanetti A, Desole MG, Romano L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.
PubMed 28624307
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA
- ClinicalTrials.gov ID
- NCT02012998
- Acronym / sponsor ID
- HXV02C
- Conditions
- Virus Diseases, Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Dec 2013 (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.
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBVAXPRO Challenge dose | Experimental | Biological: HBVAXPRO 5µgHBVAXPRO 5µg |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy child
- Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
- Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose
Key exclusion criteria (10 listed)
- Receipt of more than 3 doses of any Hepatitis B containing vaccine
- History of clinical diagnosis of infection due to Hepatitis B
- History or current close contact with known carriers of Hepatitis B virus
- Prior known sensitivity or allergy to any component of HBVAXPRO
- Chronic illness / medical condition that could interfere with study conduct or completion
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 |
|---|---|---|
| HBVAXPRO 5µgAlso: Hepatitis B vaccine (rDNA)0.5mL intramuscular injection | Biological | HBVAXPRO Challenge dose |
Primary outcome
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time frame: One month after the challenge dose
4 secondary outcomes
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Time frame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia
Time frame: Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time frame: Day 0 to day 14 after vaccination
Serious adverse events
Time frame: From signature of the informed consent to the last visit of the subject, an expected average of one month
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 11 Sep 2017.
- Derived from this study: PubMed 28624307Zanetti A, Desole MG, Romano L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.
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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.
Medical Director study director
Sanofi Pasteur, a Sanofi Company
10 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 HBVAXPRO 5µg in people with Virus Diseases and Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 10 sites in Italy.
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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL (time frame: One month after the challenge dose). 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 NCT02012998, 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 11 Sep 2017.