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

A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452621

Enrollment

235

Registered

2007-03-27

Start date

2007-02-28

Completion date

Unknown

Last updated

2008-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalitis, Tick-Borne

Keywords

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

Brief summary

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

Interventions

PROCEDUREblood draw

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

Yes

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 informed consent.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026