TBE Seropersistence up to 10 Years After First Booster in Adults

Pfizer

Status and phase: Completed; Phase 4

Conditions: Tick-borne Encephalitis (TBE)

Treatments: Biological: FSME-IMMUN 0.5 ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582698

B9371010 (Other Identifier)

691101

2011-005557-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

243 participants in 1 patient group

Seropersistence evaluation + 2nd booster vaccination

Experimental group

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.

Treatment:

Biological: FSME-IMMUN 0.5 ml