NCT00161863

Brief Summary

The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_3

Geographic Reach
3 countries

8 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.7 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

Tick-borne Encephalitis

Interventions

FSME-IMMUN NEW 0.25 mlBIOLOGICAL

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children and adolescents will be eligible for participation in this study if:
  • they are aged 1 year (from the 1st birthday) to \< 16 years (to the last day before the 16th birthday);
  • they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
  • their parents/legal guardians understand the nature of the study and agree to its provisions;
  • written informed consent is available from both parents/legal guardians,
  • for Germany/Austria: additional written informed consent is available for children older than 8 years
  • they or their parents/legal guardians agree to keep a volunteer diary.
  • \- negative pregnancy test at study entry;

You may not qualify if:

  • Children and adolescents will be excluded from participation in this study if they:
  • have a history of any TBE vaccination;
  • have a history of TBE infection;
  • have a history of allergic reactions 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, chemotherapeutics) that can be expected to influence immunological functions;
  • are known to be HIV positive (a special HIV test is not required for the purpose of the study);
  • have received banked blood or immunoglobulins within one month of study entry;
  • have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
  • suffer from hemorrhagic diathesis;
  • are participating simultaneously in another clinical trial;
  • if female: are pregnant or breastfeeding.
  • Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.
  • If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
  • Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Grieskirchner Strasse 17

Wels, 4600, Austria

Location

Marktplatz 3

Bad Saulgau, 88348, Germany

Location

Solothurner Strasse 2

Heilbronn, 74072, Germany

Location

Hauptstraße 240

Kehl, 77694, Germany

Location

Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny

Kielce, 25381, Poland

Location

Szpital Jana Pawla II Odz. Neuroinfekcji

Krakow, 31202, Poland

Location

Samodzielny Publiczny ZOZ Oddzial Dzieciecy

Lubartów, 21100, Poland

Location

PANTAMED sp.z.o.o.

Olsztyn, 10-461, Poland

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

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

Study Officials

  • Baxter BioScience Investigator

    Baxter BioScience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

September 1, 2002

Study Completion

January 1, 2003

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

DE(3)PL(4)AU(1)