CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 179 enrolled
Drug / intervention
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)biological
Likely dose
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)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00894686
NCT00894686Phase 4Completed
CompareCT.gov

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)

Pfizer·interventional·Posted May 7, 2009·Updated Dec 17, 2018

In Brief

A Phase 4 clinical trial evaluating 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) for Encephalitis, Tick-Borne. Completed, enrolled 179 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis, Tick-Borne
CountriesAustria, Germany, Poland
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2009
Enrollment StartApr 26, 2009
Primary CompletionMay 10, 2017
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 17.2 years ago

Interventions

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)biological

Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.