Trial record 2 of 31 for:
"Encephalitis, Tick-Borne"
Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)
This study is ongoing, but not recruiting participants.
Sponsor:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00894686
First received: April 30, 2009
Last updated: July 11, 2012
Last verified: July 2012
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Purpose
The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
| Condition | Intervention | Phase |
|---|---|---|
|
Encephalitis, Tick-Borne |
Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Open-label Phase 4 Study to Investigate the Seropersistence of Tick-Borne Encephalitis (TBE) Virus Antibodies After the First Booster Vaccination and the Response to a Second Booster Vaccination With FSME-IMMUN in Children, Adolescents and Young Adults (Follow-Up to Study 700401) |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Seropositivity rate after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 160 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: All subjects
Assessment of seropersistence of TBE antibodies at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (in Study 700401), as well as antibody response to a second booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL, depending on the subject´s age. Timing of the second booster vaccination will depend on the level of serum TBE antibodies detected at the defined assessment time points. Subjects who are not protected against TBE for an entire further season (NT titer <= 20 and/or ELISA value < 126 VIE U/mL) will be invited to receive the second booster vaccination at either the 40, 48, 60, 72, 84, 96, 108, or 120-month time point.
|
Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:
- Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
- Subject provides written assent to the study according to age and capacity of understanding;
- Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
- Blood was drawn after the first booster vaccination in precursor Study 700401;
- Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).
Exclusion Criteria:
Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:
- Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
- Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
- Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
- Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
- Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
- Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894686
Locations
| Austria | |
| Untergraben 2 | |
| Eferding, Austria, 4070 | |
| Grieskirchner Strasse 17 | |
| Wels, Austria, 4600 | |
| Germany | |
| Haupstrasse 240 | |
| Kehl, Germany, 77694 | |
| Poland | |
| Niepubliczny ZOZ | |
| Zamosc, Poland, 22400 | |
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
| Study Director: | Eva-Maria Pöllabauer, MD | Baxter Healthcare Corporation |
More Information
No publications provided
| Responsible Party: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00894686 History of Changes |
| Other Study ID Numbers: | 700802 |
| Study First Received: | April 30, 2009 |
| Last Updated: | July 11, 2012 |
| Health Authority: | Austria: Federal Ministry for Health Family and Youth Germany: Paul-Ehrlich-Institut Poland: Ministry of Health |
Additional relevant MeSH terms:
|
Encephalitis, Tick-Borne Encephalitis 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 |
ClinicalTrials.gov processed this record on June 17, 2013