Status:

COMPLETED

Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

Lead Sponsor:

Pfizer

Conditions:

Encephalitis, Tick-borne

Eligibility:

All Genders

6-47 years

Phase:

PHASE2

PHASE3

Brief Summary

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whet...

Eligibility Criteria

Inclusion

  • Male and female children aged between 6 and 47 months
  • No history of any previous TBE vaccination
  • Clinically healthy
  • Informed consent provided by the parents

Exclusion

  • History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
  • Suffering from a disease that cannot be effectively treated or stabilised
  • Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
  • Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
  • HIV-positivity (no special HIV test required for the purpose of the study)
  • Suffering from a febrile disease
  • History of vaccination against yellow fever and/or Japanese encephalitis
  • Participation in another clinical trial

Key Trial Info

Start Date :

April 1 1998

Trial Type :

INTERVENTIONAL

End Date :

June 1 1999

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00161746

Start Date

April 1 1998

End Date

June 1 1999

Last Update

May 21 2015

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Wiener Strasse 50/2

Kapfenberg, Austria, 8605

2

Erzherzog Johann Strasse 9

Leoben, Austria, 8700

3

Fronleichnamsweg 10

Liezen, Austria, 8940

4

Hauptstrasse 61

Linz, Austria, 4040

Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years | DecenTrialz