Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

PHASE3CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

February 6, 2009

Primary Completion Date

May 20, 2010

Study Completion Date

May 20, 2010

Conditions
Encephalitis, Tick-Borne
Interventions
BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360

BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.

Trial Locations (8)

4070

Unterer Graben 2, Eferding

4600

Grieskirchnerstr.17, Wels

50005

University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581, Hradec Králové

580 01

Private surgery of General Practitioner for children and juveniles, Havlíčkův Brod

530 02

Private surgery of General Practitioner for children and juveniles, Pardubice

530 03

Private surgery of General Practitioner for children and juveniles, Pardubice

530 09

Private surgery of General Practitioner for children and juveniles, Pardubice

Chemiku 129, Pardubice-Polabiny

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY