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

NCT ID: NCT00161824

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2002-01-31

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.

Conditions

Encephalitis, Tick-borne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jerzy Romaszko, MD

Role: PRINCIPAL_INVESTIGATOR

PANTAMED sp. z o o.

Jerzy Brzostek, MD

Role: PRINCIPAL_INVESTIGATOR

Zespol Opieki Zdrowotnej w Debicy

Jerzy Dziduch, MD

Role: PRINCIPAL_INVESTIGATOR

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Krystnyna Jurowska, MD

Role: PRINCIPAL_INVESTIGATOR

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Marian Patrzalek, MD

Role: PRINCIPAL_INVESTIGATOR

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Krzysztof Sladek, MD

Role: PRINCIPAL_INVESTIGATOR

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Ryszard Konior, MD

Role: PRINCIPAL_INVESTIGATOR

Szpital Jana Pawla II Oddzial Neuoinfekcji

Locations

Zespol Opieki Zdrowotnej w Debicy

Dębica, , Poland

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Kielce, , Poland

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Krakow, , Poland

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Krakow, , Poland

Szpital Jana Pawla II Oddzial Neuroinfekcji

Krakow, , Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, , Poland

PANTAMED sp. z o.o.

Olsztyn, , Poland

Countries

Poland

Other Identifiers

208

Identifier Type: -

Identifier Source: org_study_id