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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161785

Enrollment

340

Registered

2005-09-13

Start date

2004-06-30

Completion date

2005-07-31

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-borne Encephalitis

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.

Interventions

BIOLOGICALFSME-IMMUN 0.5ml

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 67 Years

Healthy volunteers

Yes

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/

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026