NCT01582698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2012

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

April 20, 2012

Last Update Submit

January 20, 2021

Conditions

Tick-borne Encephalitis (TBE)

Outcome Measures

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

    118 months

Secondary Outcomes (3)

  • 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

    118 months

  • 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

    118 months

  • 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

    118 months

Study Arms (1)

Seropersistence evaluation + 2nd booster vaccination

EXPERIMENTAL

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

Interventions

FSME-IMMUN 0.5 mlBIOLOGICAL

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.

Seropersistence evaluation + 2nd booster vaccination

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prywatny Gabinet Lekarski

Dębica, 39-200, Poland

Location

"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology

Krakow, 31-202, Poland

Location

Related Publications (1)

  • Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22.

    PMID: 28545923DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

PL(2)