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

NCT00161876 | Completed Phase 3

• 1 other identifier: 213
• Study Type: interventional
• Target: 3,973
• Locations: 1 country
• Sites: 8

Brief Summary

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).

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) BIOLOGICAL

Eligibility Criteria

• Age: 16 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Zespol Opieki Zdrowotnej w Debicy

Dębica, 33-200, Poland

Location

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Kielce, 25-381, Poland

Location

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Krakow, 30-018, Poland

Location

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Krakow, 30-969, Poland

Location

Szpital Jana Pawla II Oddzial Neuroinfekcji

Krakow, 31-202, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, 21-100, Poland

Location

PANTAMED sp. z o.o.

Olsztyn, 10-461, Poland

Location

Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika

Tarnów, 33-100, Poland

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• 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

• Krystyna 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

  Szpital Jana Pawla II Oddzial Neuoinfekcji

  PRINCIPAL INVESTIGATOR

• Grazyna Zawada-Skrobisz, MD

  Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: May 1, 2002
• Study Completion: August 1, 2002
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

PL (8)