FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 Years

The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR 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: 3973
• 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.
  • Tarnow, Poland, 33-100
    • Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Received two vaccinations during the course of Baxter study 208
• Understand the nature of the study, agree to its provisions and give written informed consent
• For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given

Exclusion Criteria:

• None.

Volunteers assessed for eligibility to receive a third vaccination.

Eligibility to receive third vaccination:

• ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
• Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
• Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
• Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
• Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
• Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages)
• Have received banked human blood or immunoglobulins within one month of study entry
• Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
• Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
• Have received an investigational new drug within 6 weeks prior to study start
• Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
• Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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: 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: Krystyna Jurowska, MD, Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"; Principal Investigator: Ryszard Konior, Szpital Jana Pawla II Oddzial Neuoinfekcji; Principal Investigator: Grazyna Zawada-Skrobisz, MD, Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Study Completion: August 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

• Keywords: tick-borne encephalitis
• 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: 213