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

NCT ID: NCT00161876

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3973 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2002-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jerzy Romaszko, MD

Role: PRINCIPAL_INVESTIGATOR

PANTAMED sp. z o o.

Jerzy Brzostek, MD

Role: PRINCIPAL_INVESTIGATOR

Zespol Opieki Zdrowotnej w Debicy

Jerzy Dziduch, MD

Role: PRINCIPAL_INVESTIGATOR

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Krystyna Jurowska, MD

Role: PRINCIPAL_INVESTIGATOR

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Marian Patrzalek, MD

Role: PRINCIPAL_INVESTIGATOR

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Krzysztof Sladek, MD

Role: PRINCIPAL_INVESTIGATOR

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Ryszard Konior

Role: PRINCIPAL_INVESTIGATOR

Szpital Jana Pawla II Oddzial Neuoinfekcji

Grazyna Zawada-Skrobisz, MD

Role: PRINCIPAL_INVESTIGATOR

Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow

Locations

Zespol Opieki Zdrowotnej w Debicy

Dębica, , Poland

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Kielce, , Poland

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Krakow, , Poland

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Krakow, , Poland

Szpital Jana Pawla II Oddzial Neuroinfekcji

Krakow, , Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, , Poland

PANTAMED sp. z o.o.

Olsztyn, , Poland

Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika

Tarnów, , Poland

Countries

Poland

Other Identifiers

213

Identifier Type: -

Identifier Source: org_study_id