Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00161863 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tick-borne Encephalitis | Biological: FSME-IMMUN NEW 0.25 ml | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years |
Study Start Date : | September 2002 |
Study Completion Date : | January 2003 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 15 Years (Child) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
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
- 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;
Exclusion Criteria:
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);
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161863
Austria | |
Grieskirchner Strasse 17 | |
Wels, Austria, 4600 | |
Germany | |
Marktplatz 3 | |
Bad Saulgau, Germany, 88348 | |
Solothurner Strasse 2 | |
Heilbronn, Germany, 74072 | |
Hauptstraße 240 | |
Kehl, Germany, 77694 | |
Poland | |
Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny | |
Kielce, Poland, 25381 | |
Szpital Jana Pawla II Odz. Neuroinfekcji | |
Krakow, Poland, 31202 | |
Samodzielny Publiczny ZOZ Oddzial Dzieciecy | |
Lubartow, Poland, 21100 | |
PANTAMED sp.z.o.o. | |
Olsztyn, Poland, 10-461 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
ClinicalTrials.gov Identifier: | NCT00161863 |
Other Study ID Numbers: |
209 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | May 21, 2015 |
Last Verified: | May 2015 |
Encephalitis, Tick-Borne Encephalitis Encephalitis, Arbovirus Encephalitis, Viral Infectious Encephalitis Tick-Borne Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Viral Diseases Central Nervous System Infections Infections Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections |