Clinical trial NCT00161824: Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis, Tick-borne
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 3800
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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)
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Debica
country: Poland
facility: Zespol Opieki Zdrowotnej w Debicy
city: Kielce
country: Poland
facility: Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
city: Krakow
country: Poland
facility: "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
city: Krakow
country: Poland
facility: Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
city: Krakow
country: Poland
facility: Szpital Jana Pawla II Oddzial Neuroinfekcji
city: Lubartow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
city: Olsztyn
country: Poland
facility: PANTAMED sp. z o.o.
Study officials:
affiliation: PANTAMED sp. z o o.
name: Jerzy Romaszko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zespol Opieki Zdrowotnej w Debicy
name: Jerzy Brzostek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
name: Jerzy Dziduch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
name: Krystnyna Jurowska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
name: Marian Patrzalek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
name: Krzysztof Sladek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Szpital Jana Pawla II Oddzial Neuoinfekcji
name: Ryszard Konior, MD
role: PRINCIPAL_INVESTIGATOR
References: