Tick-borne EncephalitisPhase 2NCT00161798
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
A Phase 2 study testing Tick-borne encephalitis vaccine in people with Tick-borne Encephalitis, run by Pfizer at 23 sites in Germany.
Trial summary
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tick-borne Encephalitis
- What is being tested?
- Tick-borne encephalitis vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 23 sitesGermany
- Study dates
- Sep 2001to Mar 2002
- Phase
- Phase 2
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female children will be eligible for participation in this study if:
- they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
- they are clinically healthy;
- their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
- For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
- negative pregnancy test at study start;
- they agree to employ adequate birth control measures for the duration of the study.
Who cannot join
- Children will be excluded from participation in this study if they:
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the vaccine;
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
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- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
- suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
- are known to be HIV positive (a special HIV test is not required for the purpose of the study);
- suffer from a febrile illness at study entry;
- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- are participating simultaneously in another clinical trial.
- if female, are pregnant or breast feeding
- Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Germany23 sites
Neuschwansteinstrasse 5
Augsburg, 86163
Marktplatz 33
Bad Saulgau, 88348
Hauptstrasse 9
Bietigheim-Bissingen, 74321
Salzgasse 11
Calw, 75365
Mohrenstrasse 8
Coburg, 96450
Bahnhofstrasse 1
Elzach, 79215
Rheinstrasse 13
Ettenheim, 77955
Peter-Seifert Strasse 5
Gersfeld, 36129
Solothurner Strasse 2
Heilbronn, 74072
Hauptstraße 240
Kehl, 77694
Schwarzwaldstrasse 20
Kirchzarten, 79199
Altoettingerstrasse 3
Landsberg, 86899
Rastatter Strasse 7
Mannheim-Secken, 68239
Wilhelmstrasse 25
Metzingen, 72555
Heubischer Strasse 39
Neustadt/Cbg, 96465
Dohmbuehlerstrasse 8
Nuremberg, 90449
Schwarzwaldstrasse 18
Oberkirch, 77704
Wilhelmstrasse 7
Offenburg, 77654
Asternweg 11a
Offenburg, 77656
Bergstrasse 27
Rottweil, 78628
Berneckstrasse 19
Schrammberg, 78713
Hauptstrasse 11
Tegernsee, 83681
Broner Platz 6
Weingarten, 88250
About this study
Official title: Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.
- Conditions
- Tick-borne Encephalitis
- Being tested
- Tick-borne encephalitis vaccine
- 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 vaccineBiological
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 startSep 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-borne EncephalitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ulrich Behre, MD, Principal investigator, Hauptstrasse 240, 77694 Kehl, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161798
- Sponsor's protocol ID
- 205
- Status last verified
- May 2015
- First submitted
- 8 Sep 2005
- Last updated
- 21 May 2015
- Results posted
- No
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
- Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
- ClinicalTrials.gov ID
- NCT00161798
- Acronym / sponsor ID
- 205
- Conditions
- Tick-borne Encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Mar 2002
- 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 investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
- they are clinically healthy;
- their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
- For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
Key exclusion criteria (14 listed)
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the vaccine;
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
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 vaccine | Biological | – |
Primary outcome
Not reported in the source record.
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.
Ulrich Behre, MD principal investigator
Hauptstrasse 240, 77694 Kehl, Germany
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tick-borne encephalitis vaccine in people with Tick-borne Encephalitis, run by Pfizer at 23 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 8 inclusion and 14 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 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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.