Antibody Response After VaccinationPhase 4NCT00216229
Twinrix Alternative Schedule Study
A Phase 4 study testing Combined vaccine against hepatitis A and B (Twinrix) in people with Antibody Response After Vaccination, run by IDEWE Occupational Health Services at 1 site in Belgium.
Trial summary
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months. 1. To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibody Response After Vaccination
- What is being tested?
- Combined vaccine against hepatitis A and B (Twinrix)
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2004to Feb 2006
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older;
- a good physical condition as confirmed by history and physical examination at entry of the study;
- for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
- all participants have provided written informed consent.
Who cannot join
- Employees occupationally exposed to hepatitis B virus
- Other exclusion criteria listed for the vaccine (licensed vaccine):
- Each acute disease at the inclusion in the study;
- A history of hypersensibility to one of the components of the vaccine;
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months.
- To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13.
- To compare the distribution of anti-HBs at these different moments.
- Conditions
- Antibody Response After Vaccination
- Being tested
- Combined vaccine against hepatitis A and B (Twinrix)
- Keywords
- combined hepatitis A and B vaccine, hepatitis B virus, immunity
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined vaccine against hepatitis A and B (Twinrix)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary outcomes (1)
Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody Response After VaccinationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- IDEWE Occupational Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Antoon A De Schryver, M.D., PhD, Principal investigator, IDEWE Occupational Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216229
- Sponsor's protocol ID
- IDEWE-301
- Other IDs
- 04-033
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 14 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)
- ClinicalTrials.gov ID
- NCT00216229
- Acronym / sponsor ID
- IDEWE-301
- Conditions
- Antibody Response After Vaccination
- Keywords
- combined hepatitis A and B vaccine, hepatitis B virus, immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- IDEWE Occupational Health ServicesUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2004
- Study completion
- Feb 2006
- First posted
- 22 Sep 2005 (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 compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months.
- To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13.
- To compare the distribution of anti-HBs at these different moments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older;
- a good physical condition as confirmed by history and physical examination at entry of the study;
- for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
- all participants have provided written informed consent.
Key exclusion criteria (5 listed)
- Employees occupationally exposed to hepatitis B virus
- Other exclusion criteria listed for the vaccine (licensed vaccine):
- Each acute disease at the inclusion in the study;
- A history of hypersensibility to one of the components of the vaccine;
- Simultaneous participation in another clinical trial
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 |
|---|---|---|
| Combined vaccine against hepatitis A and B (Twinrix) | Biological | – |
Primary outcome
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
1 secondary outcome
Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2005.
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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.
Antoon A De Schryver, M.D., PhD principal investigator
IDEWE Occupational Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined vaccine against hepatitis A and B (Twinrix) in people with Antibody Response After Vaccination, run by IDEWE Occupational Health Services at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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-HBs antibodies concentration 1 month after 3th vaccine dose. 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 14 Dec 2005.