Trial | NCT00161824  Report issue

Title

Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3800
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.
Study Started
Oct 31
2001
Study Completion
Jan 31
2002
Last Update
May 21
2015
Estimate

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

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)
Had donated blood or plasma within one month of the study start
Had received banked blood or immunoglobulins within one month of study entry
Known to be HIV positive (a special HIV test was not required for the purpose of the study)
Suffering from a febrile illness at study entry
History of vaccination against yellow fever and / or Japanese B encephalitis
Participating simultaneously in another clinical trial
If female: pregnant or breast feeding
No Results Posted