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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Encephalitis, Tick-borne

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00161876

213

Details and patient eligibility

About

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).

Sex: All

Ages: 16 to 66 years old

Volunteers: Accepts Healthy Volunteers

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)