Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.
Sponsor study identifier
interventional
3,800
1 country
7
Study Start
October 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2001
Date type not reportedThis date has not been verified as actual or estimated.
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2005
Actual (reported)September 13, 2005
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Zespol Opieki Zdrowotnej w Debicy
Dębica, 33-200, Poland
Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
Kielce, 25-381, Poland
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Krakow, 30-018, Poland
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Krakow, 30-969, Poland
Szpital Jana Pawla II Oddzial Neuroinfekcji
Krakow, 31-202, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
Lubartów, 21-100, Poland
PANTAMED sp. z o.o.
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"
First Submitted
September 8, 2005
First Posted
September 13, 2005
Study Start
October 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
January 2002
Date type not reportedTBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
Contact the study team to confirm eligibility.
Olsztyn, 10-461, Poland
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
This date has not been verified as actual or estimated.
Last Updated
May 21, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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