search
Back to results

Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years

Primary Purpose

Tick-borne Encephalitis

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
FSME-IMMUN 0.5ml
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female subjects 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 third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213; blood was drawn before and after their third vaccination during the course of Baxter Study 213; they showed an ELISA-concentration > 126 VIE U/ml and / or a NT-titer >= 1:10 after the third vaccination in Baxter Study 213; they agree to keep a Subject Diary. Exclusion Criteria: Subjects will be excluded from participation in this study if they: received any TBE vaccination since their third vaccination with FSME-IMMUN 0.5ml; received a vaccination against yellow fever and / or Japanese B-encephalitis since their third vaccination with FSME-IMMUN 0.5ml; are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.5ml; have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages); have received a blood transfusion or immunoglobulins within one month to the first and second blood draw; have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies). Subjects will not be eligible for booster vaccination if: they do not meet the inclusion/exclusion criteria; they are not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial); they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions; they have donated blood or plasma within one month to the booster vaccination; female of childbearing potential are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination); they have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter Study 213; they are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study. Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal. Subjects who have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed. If subjects have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

Sites / Locations

  • Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy
  • Szpital Jana Pawla II Oddzial Neuroinfekcji

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00161785
Brief Title
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess: TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT). TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-borne Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
FSME-IMMUN 0.5ml

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female subjects 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 third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213; blood was drawn before and after their third vaccination during the course of Baxter Study 213; they showed an ELISA-concentration > 126 VIE U/ml and / or a NT-titer >= 1:10 after the third vaccination in Baxter Study 213; they agree to keep a Subject Diary. Exclusion Criteria: Subjects will be excluded from participation in this study if they: received any TBE vaccination since their third vaccination with FSME-IMMUN 0.5ml; received a vaccination against yellow fever and / or Japanese B-encephalitis since their third vaccination with FSME-IMMUN 0.5ml; are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.5ml; have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages); have received a blood transfusion or immunoglobulins within one month to the first and second blood draw; have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies). Subjects will not be eligible for booster vaccination if: they do not meet the inclusion/exclusion criteria; they are not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial); they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions; they have donated blood or plasma within one month to the booster vaccination; female of childbearing potential are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination); they have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter Study 213; they are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study. Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal. Subjects who have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed. If subjects have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryszard Konior, MD
Organizational Affiliation
Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy
City
Debica
ZIP/Postal Code
33-200
Country
Poland
Facility Name
Szpital Jana Pawla II Oddzial Neuroinfekcji
City
Krakow
ZIP/Postal Code
31-202
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years

We'll reach out to this number within 24 hrs