TBE Seropersistence up to 10 Years After First Booster in Adults

Pfizer243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

243

Conditions

Tick-borne Encephalitis (TBE)

Interventions

FSME-IMMUN 0.5 mlBIOLOGICAL

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

Sex: ALLMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Prywatny Gabinet Lekarski

Dębica, Poland

"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology

Krakow, Poland

Outcomes

Primary Outcomes

Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Time frame: 118 months

Secondary Outcomes

Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Time frame: 118 months

Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT

Time frame: 118 months

Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT

Time frame: 118 months

Data from ClinicalTrials.gov

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