NCT00894686

Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

Open-label Phase Iv Study To Investigate The Seropersistence Of Tick-borne Encephalitis (Tbe) Virus Antibodies After The First Booster And The Response To A Second Booster Vaccination With Fsme-immun In Children, Adolescents And Young Adults (Follow-up To Study 700401)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.

Conditions

• Encephalitis, Tick-Borne

Interventions

Type	Name	Description
BIOLOGICAL	FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)	Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.

Timeline

• Start date: 2009-04-26
• Primary completion: 2017-05-10
• Completion: 2017-05-10
• First posted: 2009-05-07
• Last updated: 2018-12-17
• Results posted: 2018-12-17

Locations

4 sites across 3 countries: Austria, Germany, Poland