Clinical trial NCT00161876: FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis, Tick-borne
Keywords: tick-borne encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 3973
Sex: ALL
Minimum age (years): 16
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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).


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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Debica
country: Poland
facility: Zespol Opieki Zdrowotnej w Debicy
city: Kielce
country: Poland
facility: Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
city: Krakow
country: Poland
facility: "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
city: Krakow
country: Poland
facility: Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
city: Krakow
country: Poland
facility: Szpital Jana Pawla II Oddzial Neuroinfekcji
city: Lubartow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
city: Olsztyn
country: Poland
facility: PANTAMED sp. z o.o.
city: Tarnow
country: Poland
facility: Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika
Study officials:
affiliation: PANTAMED sp. z o o.
name: Jerzy Romaszko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zespol Opieki Zdrowotnej w Debicy
name: Jerzy Brzostek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
name: Jerzy Dziduch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
name: Krystyna Jurowska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
name: Marian Patrzalek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
name: Krzysztof Sladek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Szpital Jana Pawla II Oddzial Neuoinfekcji
name: Ryszard Konior
role: PRINCIPAL_INVESTIGATOR
affiliation: Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow
name: Grazyna Zawada-Skrobisz, MD
role: PRINCIPAL_INVESTIGATOR
References: