Tick Borne Encephalitis (TBE)Phase 4NCT01106482
An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
A Phase 4 study testing Serology blood draw in people with Tick Borne Encephalitis (TBE), run by Novartis Vaccines at 10 sites in Germany.
Trial summary
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tick Borne Encephalitis (TBE)
- What is being tested?
- Serology blood draw
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesGermany
- Study dates
- May 2009to May 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent
Who cannot join
- Subjects who did not receive complete schedule of primary vaccination in the parent study
- Subjects enrolled in other investigational studies at the same time and within the last three months
- Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Winkelhoferstr. 3
Ehingen, 89584
Fuggerplatz 1
Kaufering, 86916
Hauptstrasse 240
Kehl, 77694
Bismarckstr. 3
Ludwigsburg, 71634
Am Marktplatz 8
Oberkirch, 77704
Großbottwarer Str. 47
Oberstenfeld, 71720
Wilhelmstr. 7
Offenburg, 77654
Stuttgarter Str. 74
Stuttgart, 70469
Martin-Niemöller-Str. 2
Traunreut, 83301
Murnauer Str. 3
Weilheim, 82362
About this study
Official title: A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine
- Conditions
- Tick Borne Encephalitis (TBE)
- Being tested
- Serology blood draw
- Keywords
- TBE, 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.
Serology blood drawOther
Blood draw only, no vaccine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Other: Serology blood draw |
| Arm 2 | Active comparator | Not described Receives: Other: Serology blood draw |
| Arm 3 | Active comparator | Not described Receives: Other: Serology blood draw |
| Arm 4 | Active comparator | Not described Receives: Other: Serology blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Measured: 3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Measured: 4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
Measured: 5 years after vaccination
Secondary outcomes (3)
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Measured: 3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Measured: 4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
Measured: 5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 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 Borne Encephalitis (TBE)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106482
- Sponsor's protocol ID
- M48P3E1
- Status last verified
- Dec 2011
- First submitted
- 12 Apr 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
Publications
Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26.
PubMed 25728316
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
- ClinicalTrials.gov ID
- NCT01106482
- Acronym / sponsor ID
- M48P3E1
- Conditions
- Tick Borne Encephalitis (TBE)
- Keywords
- TBE, Tick Borne Encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Apr 2010 (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.
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: Serology blood draw |
| Arm 2 | Active comparator | Other: Serology blood draw |
| Arm 3 | Active comparator | Other: Serology blood draw |
| Arm 4 | Active comparator | Other: Serology blood draw |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent
Key exclusion criteria (3 listed)
- Subjects who did not receive complete schedule of primary vaccination in the parent study
- Subjects enrolled in other investigational studies at the same time and within the last three months
- Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
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 |
|---|---|---|
| Serology blood drawBlood draw only, no vaccine | Other | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Time frame: 3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Time frame: 4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
Time frame: 5 years after vaccination
3 secondary outcomes
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Time frame: 3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Time frame: 4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
Time frame: 5 years after 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 8 Dec 2011.
- Derived from this study: PubMed 25728316Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serology blood draw in people with Tick Borne Encephalitis (TBE), run by Novartis Vaccines at 10 sites in Germany.
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 3 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 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination (time frame: 3 years after vaccination). The study lists 3 primary outcomes in all. 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 NCT01106482, 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 8 Dec 2011.