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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161863 |
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.
Condition | Intervention | Phase |
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Tick-Borne Encephalitis |
Biological: FSME-IMMUN NEW 0.25 ml |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years |
Ages Eligible for Study: | 1 Year to 15 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Male and female children and adolescents will be eligible for participation in this study if:
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:
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.
Austria | |
Grieskirchner Strasse 17 | |
Wels, Austria, 4600 | |
Germany | |
Hauptstraße 240 | |
Kehl, Germany, 77694 | |
Solothurner Strasse 2 | |
Heilbronn, Germany, 74072 | |
Marktplatz 3 | |
Bad Saulgau, Germany, 88348 | |
Poland | |
Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny | |
Kielce, Poland, 25381 | |
Samodzielny Publiczny ZOZ Oddzial Dzieciecy | |
Lubartow, Poland, 21100 | |
Szpital Jana Pawla II Odz. Neuroinfekcji | |
Krakow, Poland, 31202 | |
PANTAMED sp.z.o.o. | |
Olsztyn, Poland, 10-461 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Study ID Numbers: | 209 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00161863 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Virus Diseases Tick-borne encephalitis Central Nervous System Infections Central Nervous System Diseases Healthy |
Arbovirus Infections Brain Diseases Tick-Borne Diseases Encephalitis Encephalitis, Tick-Borne |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |