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Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

NCT00161824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3800

Last updated 2015-05-21

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.

Conditions

  • Encephalitis, Tick-borne

Interventions

BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Sponsors & Collaborators

Principal Investigators

  • Jerzy Romaszko, MD · PANTAMED sp. z o o.

  • Jerzy Brzostek, MD · Zespol Opieki Zdrowotnej w Debicy

  • Jerzy Dziduch, MD · Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

  • Krystnyna Jurowska, MD · Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

  • Marian Patrzalek, MD · Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

  • Krzysztof Sladek, MD · "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

  • Ryszard Konior, MD · Szpital Jana Pawla II Oddzial Neuoinfekcji

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-31
Completion
2002-01-31

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 NCT00161824 on ClinicalTrials.gov