TBE Seropersistence up to 10 Years After First Booster in Adults

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Brief Title

TBE Seropersistence up to 10 Years After First Booster in Adults

Official Title

Open-label Phase 4 Study to Investigate the Seropersistence of Tick-borne Encephalitis (TBE) Virus Antibodies From 7 to 10 Years After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults

Brief Summary

      The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after
      the first booster TBE vaccination with FSME-IMMUN 0.5ml.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Secondary Outcome

 Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Condition

Tick-borne Encephalitis (TBE)

Intervention

FSME-IMMUN 0.5 ml

Study Arms / Comparison Groups

 Seropersistence evaluation + 2nd booster vaccination
Description:  Blood will be drawn to assess the seropersistence of TBE virus antibodies at 82, 94, 106 and 118 months after the first booster vaccination with FSME-IMMUN 0.5ml administered during the first precursor study. Timing of the second booster vaccination will depend on the level of serum TBE antibodies observed during the study. Blood will be drawn 21 - 35 days after vaccination to assess the booster response.

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

Biological

Estimated Enrollment

243

Start Date

April 2012

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

        Subjects who participated in the first and second precursor studies will be eligible for
        participation in this study if:

          -  they understand the nature of the study, agree to its provisions and provide written
             informed consent

          -  they received the first booster vaccination with FSME-IMMUN 0.5ml during the first
             precursor study and did not receive a second booster vaccination in the second
             precursor study

          -  blood was drawn after their first booster vaccination in the first precursor study

        Exclusion Criteria:

        Subjects will be excluded from participation in this study if they:

          -  received any TBE vaccination since their first booster vaccination with FSME-IMMUN
             0.5ml

          -  have a history of infection with or vaccination against other flaviviruses (e.g.
             dengue fever, yellow fever, Japanese B-encephalitis) since their first booster
             vaccination with FSME-IMMUN 0.5ml

          -  are known to be HIV positive since their first booster vaccination with FSME-IMMUN
             0.5ml

          -  have a known or suspected problem with drug or alcohol abuse
      

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pfizer CT.gov Call Center, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT01582698

Organization ID

691101

Secondary IDs

2011-005557-31

Responsible Party

Sponsor

Study Sponsor

Pfizer


Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer


Verification Date

January 2021