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CompletedNCT00311441Updated Mar 17, 2008

Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

A Phase 4 interventional study of Tick-Borne Encephalitis vaccine in Encephalitis, Tick-Borne, sponsored by Novartis. Completed at 1 site in Germany. Open to participants aged 1 Year to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-17.

Sponsored by Novartis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

02

Conditions studied

  • Encephalitis, Tick-Borne

Keywords

  • TBE, children, vaccine
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

This study's enrollment of 300 is above the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male and female children, 1 to 10 years of age.

Exclusion criteria

Exclusion Criteria:

  • Subjects with documented evidence of TBE
  • Subjects, who have been previously vaccinated against TBE
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
300 participants

Interventions

  • BiologicalTick-Borne Encephalitis vaccine
06

What researchers measure

Primary outcomes

  1. Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.

Secondary outcomes

  1. Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever

07

Study locations

1 site
  • Weilheim, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00311441
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
Apr 6, 2006
Start date
Mar 2005
Last update
Mar 17, 2008

Study contacts

Drug Information Services
study director · Novartis Vaccines & Diagnostics
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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