Hepatitis BPhase 3NCT00693186
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
A Phase 3 study testing HBVaxPRO® 5 µg / 0.5 mL and Engerix B® 10 µg / 0.5 mL in people with Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 5 sites in Italy.
Trial summary
Primary objective: To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg . Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HBVaxPRO® 5 µg / 0.5 mL and Engerix B® 10 µg / 0.5 mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 5 sitesItaly
- Study dates
- Oct 2008to Mar 2010
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy child of 4 to 7 years of age of either gender,
- Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
- Informed consent form signed by the parent(s) or by the legal representative.
- Parent(s) or legal representative able to understand and comply with the study procedures.
Who cannot join
- Any recent (<=3 days) history of febrile illness prior to vaccination,
- Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
- History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
- History or current close contact with known carriers of hepatitis B virus,
- Prior known sensitivity/allergy to any component of the study vaccines,
- Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
Show all 12Show fewer
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- Any immune impairment or humoral/cellular deficiency or depressed immunity,
- Any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
- Any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
- Any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
- Any recent (<=28 days) receipt of a live vaccine or scheduled administration through Visit 2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
Latisana, Udine
Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
Modica, 97015
Unità Operativa Semplice di Epidemiologia (UOSE)
Quarto, Napoli
AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
Ragusa, 97100
Dipartimento di Prevenzione Servizio di Igiene Pubblica
Sassari
About this study
Official title: An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA
Primary objective:
- To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .
Secondary objectives:
- Additional immunogenicity assessments
- Standard safety assessment.
- Conditions
- Hepatitis B
- Being tested
- HBVaxPRO® 5 µg / 0.5 mL, Engerix B® 10 µg / 0.5 mL
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBVaxPRO® 5 µg / 0.5 mLBiological
5 µg / 0.5 mL
Engerix B® 10 µg / 0.5 mLBiological
10 µg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: HBVaxPRO® 5 µg / 0.5 mL |
| 2 | Experimental | Not described Receives: Biological: Engerix B® 10 µg / 0.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Measured: 28 to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionMar 2010
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 BStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 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
- NCT00693186
- Sponsor's protocol ID
- HXV01C
- Status last verified
- Sep 2017
- First submitted
- 4 Jun 2008
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9.
PubMed 22789511
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, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA
- ClinicalTrials.gov ID
- NCT00693186
- Acronym / sponsor ID
- HXV01C
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jun 2008 (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.
Primary objective:
- To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .
Secondary objectives:
- Additional immunogenicity assessments
- Standard safety assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: HBVaxPRO® 5 µg / 0.5 mL |
| 2 | Experimental | Biological: Engerix B® 10 µg / 0.5 mL |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy child of 4 to 7 years of age of either gender,
- Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
- Informed consent form signed by the parent(s) or by the legal representative.
- Parent(s) or legal representative able to understand and comply with the study procedures.
Key exclusion criteria (12 listed)
- Any recent (<=3 days) history of febrile illness prior to vaccination,
- Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
- History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
- History or current close contact with known carriers of hepatitis B virus,
- Prior known sensitivity/allergy to any component of the study vaccines,
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® 5 µg / 0.5 mL5 µg / 0.5 mL | Biological | 1 |
| Engerix B® 10 µg / 0.5 mL10 µg | Biological | 2 |
Primary outcome
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Time frame: 28 to 42 days
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 22789511Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9.
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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
5 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® 5 µg / 0.5 mL and Engerix B® 10 µg / 0.5 mL in people with Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 5 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 4 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 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 5 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 anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose (time frame: 28 to 42 days). 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 NCT00693186, 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.