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

Encephalitis, Tick-borne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161876
• Other study ID #: 213
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: May 2002
• Est. completion date: August 2002

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3973
• Est. completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 66 Years

Eligibility

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:

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Locations

Country	Name	City	State
Poland	Zespol Opieki Zdrowotnej w Debicy	Debica
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	Lubartow
Poland	PANTAMED sp. z o.o.	Olsztyn
Poland	Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika	Tarnow

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland,