ClinicalTrials.gg
CompletedNCT00311493Updated Mar 13, 2007

Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

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 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-03-13.

Sponsored by Novartis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

02

Conditions studied

  • Encephalitis, Tick-Borne

Keywords

  • TBE
  • vaccine
  • adults
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 179 is close to 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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Inclusion criteria

  • Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination

Exclusion criteria

Exclusion Criteria:

  • Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
179 participants

Interventions

  • BiologicalTick-Borne Encephalitis vaccine
06

What researchers measure

Primary outcomes

  1. Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.

Secondary outcomes

  1. Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.

07

Study locations

1 site
  • Regensburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00311493
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
Apr 6, 2006
Start date
Feb 2006
Last update
Mar 13, 2007

Study contacts

Drug Information Services
study director · Chiron Corporation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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