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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

Primary Purpose

Tick Born Encephalitis

Status

Completed

Phase

Phase 4

Locations

Czech Republic

Study Type

Interventional

Intervention

TBE vaccine for adults

About this trial

This is an interventional prevention trial for Tick Born Encephalitis focused on measuring tick born encephalitis, TBE, adults

Eligibility Criteria

15 Years - 68 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Blood draw only, no vaccine

Outcomes

Primary Outcome Measures

immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA

Secondary Outcome Measures

safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting

Full Information

NCT ID

NCT00387634

First Posted

October 11, 2006

Last Updated

November 1, 2012

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00387634

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tick Born Encephalitis

Keywords

tick born encephalitis, TBE, adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

Blood draw only, no vaccine

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Blood draw only, no vaccine

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Description

Blood draw only, no vaccine

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Description

Blood draw only, no vaccine

Intervention Type

Biological

Intervention Name(s)

TBE vaccine for adults

Intervention Description

Serology blood draw.

Primary Outcome Measure Information:

Title

immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA

Time Frame

On day 21, year 1, year 2, year 3, year 4, year 5

Secondary Outcome Measure Information:

Title

safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting

Time Frame

Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines - Information Services

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

City

Hradec Kralove

ZIP/Postal Code

500 03

Country

Czech Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

24950352

Citation

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.

Results Reference

derived

Learn more about this trial

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

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