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

Phase 3

Completed

• Conditions: Encephalitis, Tick-borne

• Registration Number: NCT00161876
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study Completion: 2002-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3973

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (8)

Zespol Opieki Zdrowotnej w Debicy; 🇵🇱 Debica, Poland

PANTAMED sp. z o.o.; 🇵🇱 Olsztyn, Poland

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"; 🇵🇱 Krakow, Poland

Szpital Jana Pawla II Oddzial Neuroinfekcji; 🇵🇱 Krakow, Poland

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A; 🇵🇱 Kielce, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny; 🇵🇱 Lubartow, Poland

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego; 🇵🇱 Krakow, Poland

Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika; 🇵🇱 Tarnow, Poland