Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

NCT00163540 | Completed Phase 4

• 1 other identifier: 690501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

Interventions

Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl BIOLOGICAL

Eligibility Criteria

• Age: 17 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects who:
• received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225
• understand the nature of the study, agree to its provisions and provide written informed consent
• are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the 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

You may not qualify if:

• Subjects who:
• have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225
• have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)
• have had an allergic reaction to one of the components of the vaccine since participation in Study 225
• suffer from a disease (e.g. autoimmune disease, immunodeficiency) 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 doses 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 this study)
• are simultaneously participating in another clinical trial including administration of an investigational product
• have participated in any other clinical study within 6 weeks prior to study start
• have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)
• For female subjects: pregnancy or lactation

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

SGS Biopharma Research Unit Stuivenberg

Antwerp, 2060, Belgium

Location

Related Publications (1)

• Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, Loew-Baselli A, Poellabauer EM, Ehrlich HJ, Barrett PN, Kreil TR. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011 Jun 1;203(11):1556-64. doi: 10.1093/infdis/jir122.

  PMID: 21592984 DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

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

Study Officials

• Baxter BioScience Investigator, MD

  Baxter BioScience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2005
• Study Completion: June 1, 2005
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

BE (1)