Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387634

Enrollment

323

Registered

2006-10-13

Start date

2006-09-30

Completion date

2011-10-31

Last updated

2012-11-02

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

Conditions

Tick Born Encephalitis

Keywords

tick born encephalitis, TBE, adults

Brief summary

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

Interventions

BIOLOGICALTBE vaccine for adults

Serology blood draw.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 68 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy subjects who have completed study V48P7

Exclusion criteria

* acute illness at day of immunization * general decrease in resistance * progressive neurological disorders * history of febrile or afebrile convulsions * major congenital defects * serious chronic illness * hypersensitivity to study vaccine * treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Design outcomes

Primary

Measure	Time frame
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA	On day 21, year 1, year 2, year 3, year 4, year 5

Secondary

Measure	Time frame
safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting	Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026