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TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

NCT00503529 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2015-05-21

No results posted yet for this study

Summary

The purpose of this study is to assess:

* TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT),
* TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT,
* Safety of FSME-IMMUN 0.5ml after the second booster vaccination.

Conditions

  • Encephalitis, Tick-Borne

Interventions

BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)

Sponsors & Collaborators

Principal Investigators

  • Ryszard Konior, MD · The John Paul II Hospital, Krakow, Poland

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • Poland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503529 on ClinicalTrials.gov