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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00161785
Other study ID # 223
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated May 20, 2015
Start date June 2004
Est. completion date July 2005

Study information

Verified date May 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess:

- TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT).

- TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
FSME-IMMUN 0.5ml


Locations

Country Name City State
Poland Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy Debica
Poland Szpital Jana Pawla II Oddzial Neuroinfekcji Krakow

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

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