Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.

Pfizer7 sites in 1 country3,800 target enrollmentOctober 2001

ConditionsEncephalitis, Tick-borne

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Encephalitis, Tick-borne
Sponsor: Pfizer
Enrollment: 3800
Locations: 7
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.

Registry

clinicaltrials.gov

Start Date

October 2001

End Date

January 2002

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Male and female volunteers were eligible for participation in this study if they:
•Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
•Were clinically healthy
•Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
•Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
•Provided written informed consent
•For volunteers under 18 years of age - written informed consent of the parents / guardian was available
•Agreed to keep a volunteer diary

Exclusion Criteria

•History of any previous TBE vaccination
•History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml)
•History of allergic reactions, in particular to one of the components of the vaccine
•Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
•Received antipyretics within 4 hours prior to the first TBE vaccination
•Suffer from a disease that cannot be effectively treated or stabilized
•Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions
•Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system
•Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)
•Had a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages)