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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00840801 |
Purpose
The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
| Condition | Intervention | Phase |
|---|---|---|
|
Encephalitis, Tick-Borne |
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Single-blind, Randomized, Phase 3B Study in Children Aged 1 - 11 Years to Investigate the Immunogenicity, Safety and Interchangeability of Two Tick-borne Encephalitis (Tbe) Vaccines Administered According to a Conventional Schedule |
| Enrollment: | 302 |
| Study Start Date: | February 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
|
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
|
|
Experimental: 2
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
|
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
|
Eligibility| Ages Eligible for Study: | 1 Year to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
Exclusion Criteria:
Subjects will be excluded from participation if:
Contacts and Locations| Austria | |
| Unterer Graben 2 | |
| Eferding, Upper Austria, Austria, 4070 | |
| Grieskirchnerstr.17 | |
| Wels, Upper Austria, Austria, 4600 | |
| Czech Republic | |
| Private surgery of General Practitioner for children and juveniles | |
| Havlickuv Brod, Czech Republic, 580 01 | |
| University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581 | |
| Hradec Králové, Czech Republic, 50005 | |
| Private surgery of General Practitioner for children and juveniles | |
| Pardubice, Czech Republic, 530 03 | |
| Private surgery of General Practitioner for children and juveniles | |
| Pardubice, Czech Republic, 530 02 | |
| Private surgery of General Practitioner for children and juveniles | |
| Pardubice, Czech Republic, 530 09 | |
| Chemiku 129 | |
| Pardubice-Polabiny, Czech Republic, 530 09 | |
| Principal Investigator: | Baxter Bioscience Investigator | Baxter BioScience |
More Information
| Responsible Party: | Jael Wiertz, Clinical Project Manager, Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00840801 History of Changes |
| Other Study ID Numbers: | 700801, EUDRACT NUMBER: 2008-002691-10 |
| Study First Received: | February 9, 2009 |
| Last Updated: | August 2, 2010 |
| Health Authority: | Austria: Federal Office for Safety in Health Care; Czech Republic: State Institute for Drug Control |
|
Encephalitis Encephalitis, Tick-Borne Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections |
Encephalitis, Arbovirus Arbovirus Infections Tick-Borne Diseases Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |