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

November 1, 2012 updated by: Novartis Vaccines

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 2
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 3
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 4
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
On day 21, year 1, year 2, year 3, year 4, year 5

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Investigators

  • Study Chair: Novartis Vaccines - Information Services, Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V48P7E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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