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OpenTrials
Completed

NCT Number: NCT01582698

TBE Seropersistence up to 10 Years After First Booster in Adults

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.

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Key information

Conditions

Tick-borne Encephalitis (TBE) Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Tick-Borne Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prywatny Gabinet Lekarski, Dębica, Poland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FSME-IMMUN 0.5 ml

Biological

Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.

Primary outcomes

  1. 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

    Time frame: 118 months

Secondary outcomes

  1. 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

    Time frame: 118 months

  2. Antibody titers 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 measured by ELISA and by NT

    Time frame: 118 months

  3. Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT

    Time frame: 118 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2012
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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