|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Experimental
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, Upper Austria | |
| Grieskirchnerstr.17 | |
| Wels, Upper Austria, Austria, 4600 | |
| Unterer Graben 2 | |
| Eferding, Upper Austria, Austria, 4070 | |
| Czech Republic | |
| Faculty of Military Health Sciences, Trebesska 1575 | |
| Hradec Kralove, Czech Republic, 500 01 | |
| University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581 | |
| Hradec Králové, Czech Republic, 50005 | |
| Chemiku 129 | |
| Pardubice-Polabiny, Czech Republic, 530 09 | |
| Trebesska 1575 | |
| Hradec Králové, Czech Republic, 500 01 | |
| Children departement, Regional Hospital Pardubice, Kyjevská 44 | |
| Pardubice, Czech Republic, 532 03 | |
| Strossova 964 | |
| Pardubice, Czech Republic, 530 03 | |
| Havlickova 2034 | |
| Havlickuv Brod, Czech Republic, 580 01 | |
| Zeleznicniho pluku 2005 | |
| Pardubice, Czech Republic, 530 02 | |
| Kosmonautu 399 | |
| Pardubice, Czech Republic, 530 09 | |
| Principal Investigator: | Baxter Bioscience Investigator | Baxter BioScience |
More Information
| Responsible Party: | Baxter Healthcare Corporation ( Jael Wiertz, Clinical Project Manager ) |
| Study ID Numbers: | 700801, EUDRACT NUMBER: 2008-002691-10 |
| Study First Received: | February 9, 2009 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00840801 History of Changes |
| Health Authority: | Austria: Federal Office for Safety in Health Care; Czech Republic: State Institute for Drug Control |
|
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Nervous System Diseases Central Nervous System Diseases Central Nervous System Viral Diseases Brain Diseases Encephalitis |
Tick-Borne Diseases Encephalitis, Tick-Borne Virus Diseases Encephalitis, Viral Central Nervous System Infections Arbovirus Infections Encephalitis, Arbovirus |