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

NCT00161824 | Completed Phase 3

• 1 other identifier: 208
• Study Type: interventional
• Target: 3,800
• Locations: 1 country
• Sites: 7

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

Interventions

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Zespol Opieki Zdrowotnej w Debicy

Dębica, 33-200, Poland

Location

Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

Kielce, 25-381, Poland

Location

"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

Krakow, 30-018, Poland

Location

Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

Krakow, 30-969, Poland

Location

Szpital Jana Pawla II Oddzial Neuroinfekcji

Krakow, 31-202, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, 21-100, Poland

Location

PANTAMED sp. z o.o.

Olsztyn, 10-461, Poland

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Jerzy Romaszko, MD

  PANTAMED sp. z o o.

  PRINCIPAL INVESTIGATOR

• Jerzy Brzostek, MD

  Zespol Opieki Zdrowotnej w Debicy

  PRINCIPAL INVESTIGATOR

• Jerzy Dziduch, MD

  Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

  PRINCIPAL INVESTIGATOR

• Krystnyna Jurowska, MD

  Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"

  PRINCIPAL INVESTIGATOR

• Marian Patrzalek, MD

  Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A

  PRINCIPAL INVESTIGATOR

• Krzysztof Sladek, MD

  "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego

  PRINCIPAL INVESTIGATOR

• Ryszard Konior, MD

  Szpital Jana Pawla II Oddzial Neuoinfekcji

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: October 1, 2001
• Study Completion: January 1, 2002
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

PL (7)