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

A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311493

Enrollment

179

Registered

2006-04-06

Start date

2006-02-28

Completion date

Unknown

Last updated

2007-03-13

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

Conditions

Encephalitis, Tick-Borne

Keywords

TBE, vaccine, adults

Brief summary

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

Interventions

BIOLOGICALTick-Borne Encephalitis vaccine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

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