NCT00161954

Brief Summary

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

First QC Date

September 8, 2005

Last Update Submit

May 20, 2015

Conditions

Encephalitis, Tick-borne

Keywords

Tick-Borne Encephalitis

Interventions

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

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Understanding the nature of the study, agreement to its provisions and written informed consent
  • Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
  • Aged \>= 16 years (from the 16th birthday) to \<= 65 years (to the last day before the 66th birthday)
  • Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
  • Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
  • Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
  • Agreeing to keep a subject diary.

You may not qualify if:

  • History of any previous TBE vaccination
  • History of TBE infection
  • History of infection with other flaviviruses
  • History of vaccination against yellow fever and/or Japanese B-encephalitis
  • History of allergic reactions, in particular to one of the components of the vaccine
  • Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
  • Known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages)
  • Donation of blood or plasma within one month of study start
  • Having received a blood transfusion or immunoglobulins within one month of study entry
  • HIV positivity (an HIV test is not required specifically for the purpose of this study
  • Simultaneous participation in another clinical trial including administration of an investigational product
  • Participating in any other clinical study within six weeks prior to study start
  • Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
  • Pregnancy or lactation (if female)
  • Having received any other vaccination within two weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 21592984DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Baxter BioScience Investigator

    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 13, 2005

Study Start

March 1, 2004

Study Completion

May 1, 2004

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

BE(1)