Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

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Brief Title

Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

Official Title

A Phase IV, Open-label, Single-center Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

Brief Summary

      The aim of this study is to investigate the immunogenicity response in adults up to 10 years
      after one booster dose. Data collected from this study will allow for greater information to
      prescribers who administer TBE vaccine, so that they can appropriately time the
      administration of booster vaccinations to individuals who received different vaccination
      schedules and who live in tick borne encephalitis endemic regions.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2


Condition

Tick Borne Encephalitis

Intervention

Blood draw

Study Arms / Comparison Groups

 TBE_R Group
Description:  Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).

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

206

Start Date

March 8, 2012

Completion Date

September 30, 2016

Primary Completion Date

September 30, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects who have completed prior study - V48P7E1.

        Exclusion Criteria:

          -  Subjects whose antibody responses to booster vaccine received in the parent study fell
             below protective levels, subjects who have been exposed to TBE or flavivirus vaccine,
             subjects with immunosuppression.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

GSK Clinical Trials, , 

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations


NCT ID

NCT01562444

Organization ID

205335

Secondary IDs

2011-003255-19

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Collaborators

 Novartis Vaccines

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

June 2018