Status:
COMPLETED
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
Lead Sponsor:
Pfizer
Conditions:
Tick-borne Encephalitis
Eligibility:
All Genders
18-67 years
Phase:
PHASE4
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00161785
Start Date
June 1 2004
End Date
July 1 2005
Last Update
May 21 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy
Dębica, Poland, 33-200
2
Szpital Jana Pawla II Oddzial Neuroinfekcji
Krakow, Poland, 31-202