An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

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Brief Title

An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Official Title

A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Brief Summary

      This study will evaluate the durability of antibody responses in children and adolescents
      after primary immunization with TBE vaccine
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination

Secondary Outcome

 Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination

Condition

Tick Borne Encephalitis (TBE)

Intervention

Serology blood draw

Study Arms / Comparison Groups

 Arm 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

126

Start Date

May 2009

Completion Date

May 2011

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy study subjects from the parent study who completed the primary vaccination
             series, with parental or legal guardian informed consent

        Exclusion Criteria:

          -  Subjects who did not receive complete schedule of primary vaccination in the parent
             study

          -  Subjects enrolled in other investigational studies at the same time and within the
             last three months

          -  Subjects with any condition which, in the opinion of the investigator, might interfere
             with the evaluation of the study objectives
      

Gender

All

Ages

4 Years - 14 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01106482

Organization ID

M48P3E1


Responsible Party

Sponsor

Study Sponsor

Novartis Vaccines


Study Sponsor

, , 


Verification Date

December 2011