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

NCT ID: NCT00387634

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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Tick Born Encephalitis

Keywords

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tick born encephalitis, TBE, adults

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Blood draw only, no vaccine

Group Type ACTIVE_COMPARATOR

TBE vaccine for adults

Intervention Type BIOLOGICAL

Serology blood draw.

Arm 2

Blood draw only, no vaccine

Group Type ACTIVE_COMPARATOR

TBE vaccine for adults

Intervention Type BIOLOGICAL

Serology blood draw.

Arm 3

Blood draw only, no vaccine

Group Type ACTIVE_COMPARATOR

TBE vaccine for adults

Intervention Type BIOLOGICAL

Serology blood draw.

Arm 4

Blood draw only, no vaccine

Group Type ACTIVE_COMPARATOR

TBE vaccine for adults

Intervention Type BIOLOGICAL

Serology blood draw.

Interventions

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TBE vaccine for adults

Serology blood draw.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines - Information Services

Role: STUDY_CHAIR

Novartis

Locations

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Hradec Králové, , Czechia

Site Status

Countries

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Czechia

References

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Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.

Reference Type DERIVED
PMID: 24950352 (View on PubMed)

Other Identifiers

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V48P7E1

Identifier Type: -

Identifier Source: org_study_id