Hepatitis APhase 3NCT00483470
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
A Phase 3 study testing Hepatitis A vaccine AVAXIM 80U and Hepatitis A vaccine (HAVRIX 720) in people with Hepatitis A, run by Sanofi Pasteur, a Sanofi Company at 3 sites in China.
Trial summary
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety Read more about this study
- Who is it for?
- Ages 12 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Hepatitis A vaccine AVAXIM 80U and Hepatitis A vaccine (HAVRIX 720)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2007to Aug 2008
- 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 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria to be checked at the screening visit (SC):
- Toddlers, children and adolescents:
- Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
- Sub-Group 2: from 4 to 6 years of age on the day of inclusion
- Sub-Group 3: from 7 to 9 years of age on the day of inclusion
- Sub-Group 4: from 10 to 12 years of age on the day of inclusion
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- Sub-Group 5: from 13 to 15 years of age on the day of inclusion
- Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
- Inclusion criteria to be checked at the inclusion visit (V01):
- Toddlers, children and adolescents:
- Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
- Sub-Group 2: from 4 to 6 years of age on the day of inclusion
- Sub-Group 3: from 7 to 9 years of age on the day of inclusion
- Sub-Group 4: from 10 to 12 years of age on the day of inclusion
- Sub-Group 5: from 13 to 15 years of age on the day of inclusion
- Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
- Able to attend all scheduled visits and to comply with all trial procedures
- Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
- Subject HBsAg seronegative and ALT <40 IU/l according to the screening results
Who cannot join
- Exclusion criteria to be checked at the inclusion visit (V01):
- Participation in another clinical trial in the 4 weeks preceding trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
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- Blood or blood-derived products received in the past 3 months
- Any vaccination in the 4 weeks preceding the trial vaccination
- Any vaccination planned in the 4 weeks following the trial vaccination
- History of hepatitis A infection (confirmed either clinically or serologically )
- Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of /current seizures
- Clinical or serological evidence of systemic illness including Hepatitis C and HIV
- Febrile (axillary temperature ≥ 37.1°C) or acute illness
Trial locations and contacts
3 sites in 1 country.
China3 sites
Study site
Guilin, Guangxi, 541001
Study site
Nanning, Guangxi, 530021
Study site
Yongfu Country, Guangxi, 541800
About this study
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
- Conditions
- Hepatitis A
- Being tested
- Hepatitis A vaccine AVAXIM 80U, Hepatitis A vaccine (HAVRIX 720)
- Keywords
- Hepatitis A
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A vaccine AVAXIM 80UBiological
Also called AVAXIM 80U Pediatric vaccine
0.5 mL, Intramuscular
Hepatitis A vaccine (HAVRIX 720)Biological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Hepatitis A vaccine AVAXIM 80U |
| 2 | Active comparator | Not described Receives: Biological: Hepatitis A vaccine (HAVRIX 720) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
Measured: 1 month post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionAug 2008
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 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
- 720 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 Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483470
- Sponsor's protocol ID
- HAF78
- Status last verified
- Jan 2014
- First submitted
- 5 Jun 2007
- Last updated
- 22 Jan 2014
- Results posted
- No
Publications
Yoon SH, Kim HW, Ahn JG, Kim IT, Kim JH, Kong KA, Kim KH. Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents. J Korean Med Sci. 2016 Jan;31(1):73-9. doi: 10.3346/jkms.2016.31.1.73. Epub 2015 Dec 24.
PubMed 26770041
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
- ClinicalTrials.gov ID
- NCT00483470
- Acronym / sponsor ID
- HAF78
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Jun 2007 (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.
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
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: Hepatitis A vaccine AVAXIM 80U |
| 2 | Active comparator | Biological: Hepatitis A vaccine (HAVRIX 720) |
Who may qualify
- Ages
- 12 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Toddlers, children and adolescents:
- Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
- Sub-Group 2: from 4 to 6 years of age on the day of inclusion
- Sub-Group 3: from 7 to 9 years of age on the day of inclusion
- Sub-Group 4: from 10 to 12 years of age on the day of inclusion
Key exclusion criteria (15 listed)
- Participation in another clinical trial in the 4 weeks preceding trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial 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 |
|---|---|---|
| Hepatitis A vaccine AVAXIM 80UAlso: AVAXIM 80U Pediatric vaccine0.5 mL, Intramuscular | Biological | 1 |
| Hepatitis A vaccine (HAVRIX 720)0.5 mL, Intramuscular | Biological | 2 |
Primary outcome
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
Time frame: 1 month post-vaccination
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 22 Jan 2014.
- Derived from this study: PubMed 26770041Yoon SH, Kim HW, Ahn JG, Kim IT, Kim JH, Kong KA, Kim KH. Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents. J Korean Med Sci. 2016 Jan;31(1):73-9. doi: 10.3346/jkms.2016.31.1.73. Epub 2015 Dec 24.
- Related InfoLink provided by the sponsor.
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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 Inc
3 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 Hepatitis A vaccine AVAXIM 80U and Hepatitis A vaccine (HAVRIX 720) in people with Hepatitis A, run by Sanofi Pasteur, a Sanofi Company at 3 sites 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 19 inclusion and 15 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine (time frame: 1 month post-vaccination). 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 NCT00483470, 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 22 Jan 2014.