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

This study has been completed.

Sponsor:

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00161824

First received: September 8, 2005

Last updated: October 18, 2006

Last verified: October 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 18, 2006

Start Date ^ICMJE

October 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00161824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind

Condition ^ICMJE

Encephalitis, Tick-Borne

Intervention ^ICMJE

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3800

Completion Date

January 2002

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female volunteers were eligible for participation in this study if they:

Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
Were clinically healthy
Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
Provided written informed consent
For volunteers under 18 years of age – written informed consent of the parents / guardian was available
Agreed to keep a volunteer diary

Exclusion Criteria:

History of any previous TBE vaccination
History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)
History of allergic reactions, in particular to one of the components of the vaccine
Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
Received antipyretics within 4 hours prior to the first TBE vaccination
Suffer from a disease that cannot be effectively treated or stabilized
Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions
Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system
Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)
Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
Had donated blood or plasma within one month of the study start
Had received banked blood or immunoglobulins within one month of study entry
Known to be HIV positive (a special HIV test was not required for the purpose of the study)
Suffering from a febrile illness at study entry
History of vaccination against yellow fever and / or Japanese B encephalitis
Participating simultaneously in another clinical trial
If female: pregnant or breast feeding

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00161824

Other Study ID Numbers ^ICMJE

208

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Jerzy Romaszko, MD	PANTAMED sp. z o o.
Principal Investigator:	Jerzy Brzostek, MD	Zespol Opieki Zdrowotnej w Debicy
Principal Investigator:	Jerzy Dziduch, MD	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
Principal Investigator:	Krystnyna Jurowska, MD	Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Principal Investigator:	Marian Patrzalek, MD	Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
Principal Investigator:	Krzysztof Sladek, MD	"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Principal Investigator:	Ryszard Konior, MD	Szpital Jana Pawla II Oddzial Neuoinfekcji

Information Provided By

Baxter Healthcare Corporation

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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