CompletedNCT01106482Updated Dec 8, 2011

An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

A Phase 4 interventional study of Serology blood draw in Tick Borne Encephalitis (TBE), sponsored by Novartis Vaccines. Completed at 10 sites in Germany. Open to participants aged 4 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-08.

Sponsored by Novartis Vaccines (formerly part of Novartis) · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 126
Allocation: Randomized
Ages: 4 Years to 14 Years
Sex: All

Study summary

This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Conditions studied

Tick Borne Encephalitis (TBE)

Browse trials for

Encephalitis, Tick-Borne 51

Keywords

TBE
Tick Borne Encephalitis

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 126 is below the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 165 studies on the registry; none are open to participants now.

First submitted before Novartis Vaccines left Novartis.

Browse Novartis Vaccines studies →All Novartis studies →

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

Who can participate

Ages eligible: 4 Years to 14 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 study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian

Exclusion criteria

Exclusion Criteria:

Subjects who did not receive complete schedule of primary vaccination in the parent study
Subjects enrolled in other studies at the same time and within the last three months
Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Terms in these criteria, in plain language(2)

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

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 126 participants (actual)

Study arms

Active comparator
Arm 1
Other: Serology blood draw
Active comparator
Arm 2
Other: Serology blood draw
Active comparator
Arm 3
Other: Serology blood draw
Active comparator
Arm 4
Other: Serology blood draw

Interventions

OtherSerology blood draw
Blood draw only, no vaccine

What researchers measure

Primary outcomes

Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Time frame: 3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Time frame: 4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
Time frame: 5 years after vaccination

Secondary outcomes

Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Time frame: 3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Time frame: 4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
Time frame: 5 years after vaccination

Study locations

10 sites

Winkelhoferstr. 3
Ehingen, 89584, Germany
Fuggerplatz 1
Kaufering, 86916, Germany
Hauptstrasse 240
Kehl, 77694, Germany
Bismarckstr. 3
Ludwigsburg, 71634, Germany
Am Marktplatz 8
Oberkirch, 77704, Germany
Großbottwarer Str. 47
Oberstenfeld, 71720, Germany
Wilhelmstr. 7
Offenburg, 77654, Germany
Stuttgarter Str. 74
Stuttgart, 70469, Germany
Martin-Niemöller-Str. 2
Traunreut, 83301, Germany
Murnauer Str. 3
Weilheim, 82362, Germany

References and documents

Publications

Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26. PubMed 25728316 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 12, 2010
First posted: Apr 20, 2010
Start: May 2009
Primary completionActual: May 2011
CompletionActual: May 2011
Last update: Dec 8, 2011

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01106482
Lead sponsor: Novartis Vaccines
Responsible party: Sponsor
First posted: Apr 20, 2010
Start date: May 2009
Primary completion: May 2011
Completion: May 2011
Last update: Dec 8, 2011

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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