Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00460486
First received: April 13, 2007
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.

Estimated Enrollment: 330
Study Start Date: September 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

  • Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
  • Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
  • Are aged >= 16 years (from the 16th birthday) at screening;
  • Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
  • Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
  • Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);
  • Agree to keep a Subject Diary.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • Have a history of any previous tick-borne encephalitis (TBE) vaccination;
  • Have a history of TBE infection;
  • Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
  • Have a history of allergic reactions, in particular to one of the components of the vaccine;
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
  • Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);
  • Have donated blood or plasma within 30 days of study entry;
  • Have received a blood transfusion or immunoglobulins within 30 days of study entry;
  • Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study);
  • Are simultaneously participating in another clinical trial including administration of an investigational product;
  • Have participated in any other clinical study within six weeks prior to study entry;
  • Are pregnant or breastfeeding (if female);
  • Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
  • Have received any other vaccination within two weeks prior to study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460486

Locations
Poland
Centrum Badan Farmakologii Klinicznej monipol
Krakow, Poland, 30-969
"PANTAMED" Sp. z o.o.
Olsztyn, Poland, 10-461
Niepubliczny ZOZ "Atarax" s.c.
Olsztyn, Poland, 10-117
Niepubliczny ZOZ "VITA"
Olsztyn, Poland, 10-295
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator, MD Baxter BioScience
  More Information

No publications provided

Responsible Party: Katrin Koelling Schlebusch, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00460486     History of Changes
Other Study ID Numbers: 690601
Study First Received: April 13, 2007
Last Updated: March 27, 2008
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Formaldehyde
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014