Tick Born EncephalitisPhase 4NCT00387634
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
A Phase 4 study testing TBE vaccine for adults in people with Tick Born Encephalitis, run by Novartis Vaccines at 1 site in Czechia.
Trial summary
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster Read more about this study
- Who is it for?
- Ages 15 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Tick Born Encephalitis
- What is being tested?
- TBE vaccine for adults
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2006to Oct 2011
- 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 15 to 68 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy subjects who have completed study V48P7
Who cannot join
- acute illness at day of immunization
- general decrease in resistance
- progressive neurological disorders
- history of febrile or afebrile convulsions
- major congenital defects
- serious chronic illness
- hypersensitivity to study vaccine
- treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
- Conditions
- Tick Born Encephalitis
- Being tested
- TBE vaccine for adults
- Keywords
- tick born encephalitis, TBE, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBE vaccine for adultsBiological
Serology blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Blood draw only, no vaccine Receives: Biological: TBE vaccine for adults |
| Arm 2 | Active comparator | Blood draw only, no vaccine Receives: Biological: TBE vaccine for adults |
| Arm 3 | Active comparator | Blood draw only, no vaccine Receives: Biological: TBE vaccine for adults |
| Arm 4 | Active comparator | Blood draw only, no vaccine Receives: Biological: TBE vaccine for adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA
Measured: On day 21, year 1, year 2, year 3, year 4, year 5
Secondary outcomes (1)
safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting
Measured: Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2011
- Study completionOct 2011
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 Tick Born EncephalitisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Information Services, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387634
- Sponsor's protocol ID
- V48P7E1
- Status last verified
- Nov 2012
- First submitted
- 11 Oct 2006
- Last updated
- 2 Nov 2012
- Results posted
- No
Publications
Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.
PubMed 24950352
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
- ClinicalTrials.gov ID
- NCT00387634
- Acronym / sponsor ID
- V48P7E1
- Conditions
- Tick Born Encephalitis
- Keywords
- tick born encephalitis, TBE, adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Oct 2006 (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.
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Biological: TBE vaccine for adultsBlood draw only, no vaccine |
| Arm 2 | Active comparator | Biological: TBE vaccine for adultsBlood draw only, no vaccine |
| Arm 3 | Active comparator | Biological: TBE vaccine for adultsBlood draw only, no vaccine |
| Arm 4 | Active comparator | Biological: TBE vaccine for adultsBlood draw only, no vaccine |
Who may qualify
- Ages
- 15 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects who have completed study V48P7
Key exclusion criteria (8 listed)
- acute illness at day of immunization
- general decrease in resistance
- progressive neurological disorders
- history of febrile or afebrile convulsions
- major congenital defects
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 |
|---|---|---|
| TBE vaccine for adultsSerology blood draw. | Biological | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA
Time frame: On day 21, year 1, year 2, year 3, year 4, year 5
1 secondary outcome
safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting
Time frame: Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the 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 2 Nov 2012.
- Derived from this study: PubMed 24950352Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.
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.
Novartis Vaccines - Information Services study chair
Novartis
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 TBE vaccine for adults in people with Tick Born Encephalitis, run by Novartis Vaccines at 1 site in Czechia.
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 1 inclusion and 8 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 2 Nov 2012. 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 Czechia. 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?
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA (time frame: On day 21, year 1, year 2, year 3, year 4, year 5). 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 NCT00387634, 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 2 Nov 2012.