Encephalitis, Tick-BornePhase 4NCT00161967
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
A Phase 4 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-Borne, run by Pfizer at 3 sites in 3 countries.
Trial summary
The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Tick-Borne
- What is being tested?
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Type of treatment
- Vaccines
- How many people
- 375 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2005to Nov 2008
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participated in Baxter study 209 and:
- They and/or their parents / legal guardians understand the nature of the study and agree to its provisions
- Written informed consent is available from the parents / legal guardians according to national law
- Written informed assent is available from the child/adolescent according to age and capacity of understanding
- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209
- Blood was drawn after their third vaccination during the course of Baxter study 209
- They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the third vaccination in Baxter study 209
- They or their parents / legal guardians agree to keep a Subject Diary
Who cannot join
- Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml
- Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml
- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml
- Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable)
- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
- Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
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- Subjects will not be eligible for booster vaccination if they:
- Do not meet the inclusion / exclusion criteria
- Are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial)
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
- Have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter study 209
- Have donated blood or plasma within 30 days of the booster vaccination if female of childbearing potential - are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
- Are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study
- Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >=38.0°C, measured orally) at the scheduled time of vaccination will not be vaccinated until their body temperature returns to normal.
- Subjects who received any vaccination within 4 weeks prior to the booster vaccination will not be vaccinated until an interval of four weeks has passed.
- If subjects received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
- Females of childbearing potential will only be vaccinated if they agree to employ adequate birth control measures from 4 weeks before the booster vaccination until the end of the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Open-label Follow-up Study to Investigate the Seropersistence of TBE Antibodies and the Booster Response to a Tick-borne Encephalitis Vaccine in Children and Adolescents Aged 3 - 18 Years
The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).
Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
- Conditions
- Encephalitis, Tick-Borne
- Being tested
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Keywords
- tick-borne encephalitis
- Medical subject headings
- Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Biological
Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001 at each available time point after the third vaccination in study 209 and separately at each available time point after the booster vaccination in this study
Measured: TBE virus antibody tests at pre-determined intervals with the last test at 21-35 days after the booster vaccination in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Encephalitis, Tick-BorneStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, Principal investigator, Baxter BioScience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161967
- Sponsor's protocol ID
- 700401
- Status last verified
- May 2015
- First submitted
- 8 Sep 2005
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Follow-up Study to Investigate the Seropersistence of TBE Antibodies and the Booster Response to a Tick-borne Encephalitis Vaccine in Children and Adolescents Aged 3 - 18 Years
- ClinicalTrials.gov ID
- NCT00161967
- Acronym / sponsor ID
- 700401
- Conditions
- Encephalitis, Tick-Borne
- Keywords
- tick-borne encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 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.
The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).
Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Participated in Baxter study 209 and:
- They and/or their parents / legal guardians understand the nature of the study and agree to its provisions
- Written informed consent is available from the parents / legal guardians according to national law
- Written informed assent is available from the child/adolescent according to age and capacity of understanding
- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209
Key exclusion criteria (17 listed)
- Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml
- Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml
- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml
- Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable)
- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
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 |
|---|---|---|
| Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age. | Biological | – |
Primary outcome
Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001 at each available time point after the third vaccination in study 209 and separately at each available time point after the booster vaccination in this study
Time frame: TBE virus antibody tests at pre-determined intervals with the last test at 21-35 days after the booster vaccination in this study
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 21 May 2015.
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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.
Baxter BioScience Investigator principal investigator
Baxter BioScience
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-Borne, run by Pfizer at 3 sites in 3 countries.
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 8 inclusion and 17 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 21 May 2015. 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 Austria, Germany, Poland. 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?
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?
Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001 at each available time point after the third vaccination in study 209 and separately at each available time point after the booster vaccination in this study (time frame: TBE virus antibody tests at pre-determined intervals with the last test at 21-35 days after the booster vaccination in this study). 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 21 May 2015.