Encephalitis, Tick-bornePhase 2NCT00161850
FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years
A Phase 2 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 25 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and… Read more about this study
- Who is it for?
- Ages 1 year to 6 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
- 615 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Feb 2002to Aug 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:
- They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
- Written informed consent from the legal guardian is available.
Who cannot join
- There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.
- Volunteers will be excluded from vaccination and consecutive visits in this study if they:
- Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199
- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
Show all 10Show fewer
- Have received banked human blood or immunoglobulins within one month of study entry
- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199
- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
- Had received an investigational new drug within 6 weeks prior to study start
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Germany24 sites
Neuschwanstein Strasse 5
Augsburg, D-86163
Marktplatz 33
Bad Saulgau, D-88348
Hauptstrasse 9
Bietigheim-Bissingen, D-74321
Salzgasse 11
Calw, D-75365
Mohrenstrasse 8
Coburg, D-96450
Bahnhofstrasse 1
Elzach, D-79215
Rheinstrasse 1a
Ettenheim, D-77955
Ehlerstrasse 17
Friedrichshafen, D-88046
Peter-Seifert Strasse 5
Gersfeld, D-36129
Solothumer Strasse 2
Heilbronn, D-74072
Hauptstrasse 240
Kehl, D-77694
Schwarzwald Strasse 20
Kirchzarten, D-79199
Altoettinger Strasse 3
Landsberg, D-86899
Rastatter Strasse 7
Mannheim-Secken, 68239
Wilhelmstrasse 25
Metzingen, D-72555
Dohmbuehler Strasse 8
Nuremberg, D-90449
Glogauer Strasse 15
Nuremberg, D-90473
Tuchbergstrasse 2
Oberndorf/Neckar, D-78727
Wilhelmstrasse 7
Offenburg, D-77654
Asternweg 11a
Offenburg, D-77656
Bergstrasse 27
Rottweil, D-78628
Berneckstrasse 19
Schramberg, D-78713
Hauptstrasse 11
Tegernsee, D-83681
Broner Platz 6
Weingarten, D-88250
About this study
Official title: Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).
- Conditions
- Encephalitis, Tick-borne
- Being tested
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- 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
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 startFeb 2002
- Study completionAug 2002
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 615 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161850
- Sponsor's protocol ID
- 206
- 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
- Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years
- ClinicalTrials.gov ID
- NCT00161850
- Acronym / sponsor ID
- 206
- Conditions
- Encephalitis, Tick-borne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Aug 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 the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:
- They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
- Written informed consent from the legal guardian is available.
Key exclusion criteria (10 listed)
- There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.
- Volunteers will be excluded from vaccination and consecutive visits in this study if they:
- Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199
- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
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) | 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.
Baxter BioScience Investigator principal investigator
Baxter Healthcare Corporation
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 25 sites in 2 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 3 inclusion and 10 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 25 sites in Germany, Austria. 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.