TBE Seropersistence up to 10 Years After First Booster in Adults
This study is ongoing, but not recruiting participants.
Sponsor:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01582698
First received: April 20, 2012
Last updated: September 28, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.
| Condition | Intervention | Phase |
|---|---|---|
|
Tick-borne Encephalitis (TBE) |
Biological: FSME-IMMUN 0.5 ml |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 From 7 to 10 Years After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination in the first precursor study and after the booster vaccination in this study [ Time Frame: 118 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination in the first precursor study and after the booster vaccination in this study [ Time Frame: 118 months ] [ Designated as safety issue: No ]
- Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ] [ Designated as safety issue: No ]
- Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 283 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Seropersistence evaluation + 2nd booster vaccination
Blood will be drawn to assess the seropersistence of TBE virus antibodies at 82, 94, 106 and 118 months after the first booster vaccination with FSME-IMMUN 0.5ml administered during the first precursor study. Timing of the second booster vaccination will depend on the level of serum TBE antibodies observed during the study. Blood will be drawn 21 - 35 days after vaccination to assess the booster response.
|
Biological: FSME-IMMUN 0.5 ml
Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.
|
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Subjects who participated in the first and second precursor studies will be eligible for participation in this study if:
- they understand the nature of the study, agree to its provisions and provide written informed consent
- they received the first booster vaccination with FSME-IMMUN 0.5ml during the first precursor study and did not receive a second booster vaccination in the second precursor study
- blood was drawn after their first booster vaccination in the first precursor study
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
- received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
- have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
- are known to be HIV positive since their first booster vaccination with FSME-IMMUN 0.5ml
- have a known or suspected problem with drug or alcohol abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582698
Locations
| Poland | |
| Prywatny Gabinet Lekarski | |
| Dębica, Poland, 39-200 | |
| "John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology | |
| Krakow, Poland, 31-202 | |
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
| Study Director: | BioScience Investigator, MD | Baxter Innovations GmbH |
More Information
No publications provided
| Responsible Party: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT01582698 History of Changes |
| Other Study ID Numbers: | 691101, 2011-005557-31 |
| Study First Received: | April 20, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Additional relevant MeSH terms:
|
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 Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013