Study title:
Evaluation of the safety and efficacy of the vaccine PB-116 in the control of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae
EU record number:
B/BE/11/V3
Company / Sponsor:
Laboratorios Hipra S.A.
Treated organism:
pigs
Indication category:
Active immunisation of fattening pigs for the prevention of the mortality, clinical signs and pulmonary lesions of the respiratory processes produced by Actinobacillus pleuropneumoniae
Genetic modification:
no new genes but deletion of a segment of gene A from which depends the haemolytic activity of the pathogen
Method of transfer of nucleic acid of interest:
Actinobacillus pleuropneumoniae strain HP-3179
Route of administration:
intramuscular
Locations in Belgium:
To be defined
Nr of subjects:
2400 pigs but about 1200 in Belgium
Foreseen duration:
to be defined
Type of procedure:
Deliberate release only
Information for the public
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Public information presented according to the provisions of Directive 2001/18/EC
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B/BE/11/V3 - Summary Notification Information Format (SNIF)Information related to the decision procedure
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16 April 2012: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
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1 August 2012: The Federal Ministers gives a final decision (positive with conditions) for this trial.