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

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

B/BE/11/V3 - Summary Notification Information Format (SNIF)

Public information presented according to the provisions of Directive 2001/18/EC

B/BE/11/V3 - Public information sheet (written by the notifier)

B/BE/11/V3 - Fiche d'information destinée au public (préparée par le notifiant)

B/BE/11/V3 - Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)

Information related to the decision procedure

B/BE/11/V3 - Advice Biosafety Advisory Council

16 April 2012: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.

B/BE/11/V3 - Decision of the Federal Ministers (FINAL DECISION)

1 August 2012: The Federal Ministers gives a final decision (positive with conditions) for this trial.