TBE Seropersistence up to 10 Years After First Booster in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tick-borne Encephalitis (TBE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FSME-IMMUN 0.5 ml

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes