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

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.

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis, Tick-borne
• Intervention / Treatment: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

• Study Type: Interventional
• Enrollment: 3800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Debica, Poland, 33-200
    • Zespol Opieki Zdrowotnej w Debicy
  • Kielce, Poland, 25-381
    • Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
  • Krakow, Poland, 31-202
    • Szpital Jana Pawla II Oddzial Neuroinfekcji
  • Krakow, Poland, 30-018
    • "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
  • Krakow, Poland, 30-969
    • Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
  • Lubartow, Poland, 21-100
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
  • Olsztyn, Poland, 10-461
    • PANTAMED sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Study Completion: January 1, 2002

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Encephalitis; Encephalitis, Tick-Borne
• Other Study ID Numbers: 208