ClinicalTrials.gg
CompletedNCT00452621Updated Apr 23, 2008

Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

A Phase 4 interventional study of blood draw in Encephalitis, Tick-Borne, sponsored by Novartis. Completed at 8 sites in Germany. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-23.

Sponsored by Novartis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
235
Allocation
Non-randomized
Ages
6 Years to 16 Years
Sex
All
01

Study summary

blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

02

Conditions studied

  • Encephalitis, Tick-Borne

Keywords

  • blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
  • TBE
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 planned enrollment of 235 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
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
235 participants (estimated)

Interventions

  • Procedureblood draw
06

What researchers measure

Primary outcomes

  1. 1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage

Secondary outcomes

  1. (2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce

07

Study locations

8 sites
  • Center 7
    Aschaffenburg, 63741, Germany
  • Center 2
    Bobingen, 86399, Germany
  • Center 11
    Eberbach /Neckar, 69412, Germany
  • Center 4
    Kaufering, 86916, Germany
  • Center 15
    Pegnitz, 91257, Germany
  • Center 1
    Weilheim i. OB, 82362, Germany
  • Center 8
    Wiesloch, 69168, Germany
  • Center 16
    Zirndorf, 90513, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00452621
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
Mar 27, 2007
Start date
Feb 2007
Last update
Apr 23, 2008

Study contacts

Novartis Vaccines
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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