Tick-borne EncephalitisPhase 3NCT00161863
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
A Phase 3 study testing FSME-IMMUN NEW 0.25 ml in people with Tick-borne Encephalitis, run by Pfizer at 8 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Tick-borne Encephalitis
- What is being tested?
- FSME-IMMUN NEW 0.25 ml
- How many people
- Not given
- Where
- 8 sitesin 3 countries
- Study dates
- Sep 2002to Jan 2003
- Phase
- Phase 3
- 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 15 years
- All sexes
- Child
Who may be able to join
- Male and female children and adolescents will be eligible for participation in this study if:
- they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);
- they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
- their parents/legal guardians understand the nature of the study and agree to its provisions;
- written informed consent is available from both parents/legal guardians,
- for Germany/Austria: additional written informed consent is available for children older than 8 years
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- they or their parents/legal guardians agree to keep a volunteer diary.
- For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:
- negative pregnancy test at study entry;
Who cannot join
- Children and adolescents will be excluded from participation in this study if they:
- have a history of any TBE vaccination;
- have a history of TBE infection;
- have a history of allergic reactions to one of the components of the vaccine;
- 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;
- are known to be HIV positive (a special HIV test is not required for the purpose of the study);
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- have received banked blood or immunoglobulins within one month of study entry;
- have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
- suffer from hemorrhagic diathesis;
- are participating simultaneously in another clinical trial;
- if female: are pregnant or breastfeeding.
- Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
- Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.
- If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
- Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Poland4 sites
Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
Kielce, 25381
Szpital Jana Pawla II Odz. Neuroinfekcji
Krakow, 31202
Samodzielny Publiczny ZOZ Oddzial Dzieciecy
Lubartów, 21100
PANTAMED sp.z.o.o.
Olsztyn, 10-461
Germany3 sites
Marktplatz 3
Bad Saulgau, 88348
Solothurner Strasse 2
Heilbronn, 74072
Hauptstraße 240
Kehl, 77694
About this study
Official title: Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
- Conditions
- Tick-borne Encephalitis
- Being tested
- FSME-IMMUN NEW 0.25 ml
- 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.
FSME-IMMUN NEW 0.25 mlBiological
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 2002
- Study completionJan 2003
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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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
- NCT00161863
- Sponsor's protocol ID
- 209
- 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
- Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
- ClinicalTrials.gov ID
- NCT00161863
- Acronym / sponsor ID
- 209
- Conditions
- Tick-borne Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Jan 2003
- 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 of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male and female children and adolescents will be eligible for participation in this study if:
- they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);
- they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
- their parents/legal guardians understand the nature of the study and agree to its provisions;
- written informed consent is available from both parents/legal guardians,
Key exclusion criteria (15 listed)
- have a history of any TBE vaccination;
- have a history of TBE infection;
- have a history of allergic reactions to one of the components of the vaccine;
- 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;
- are known to be HIV positive (a special HIV test is not required for the purpose of the study);
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 |
|---|---|---|
| FSME-IMMUN NEW 0.25 ml | 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 BioScience
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FSME-IMMUN NEW 0.25 ml in people with Tick-borne Encephalitis, run by Pfizer at 8 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 9 inclusion and 15 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 8 sites in Poland, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.