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Trial record 3 of 26 for:    FSME-Immun
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TBE Seropersistence up to 10 Years After First Booster in Adults

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ClinicalTrials.gov Identifier: NCT01582698
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tick-borne Encephalitis (TBE) Biological: FSME-IMMUN 0.5 ml Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Seropersistence evaluation + 2nd booster vaccination
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.
 Biological: FSME-IMMUN 0.5 ml
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582698


Locations
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Poland
Prywatny Gabinet Lekarski
Dębica, Poland, 39-200
"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology
Krakow, Poland, 31-202
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01582698    
Other Study ID Numbers: 691101
2011-005557-31 ( EudraCT Number )
B9371010 ( Other Identifier: Pfizer )
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Tick-Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections