TBE Seropersistence up to 10 Years After First Booster in Adults

Tick-borne Encephalitis (TBE) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582698
• Other study ID #: 691101
• Secondary ID: 2011-005557-31B9
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-borne Encephalitis (TBE)

Intervention

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.

Locations

Country	Name	City	State
Poland	Prywatny Gabinet Lekarski	Debica
Poland	"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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