Evaluation of the local and general safety of a single administration of Suvaxyn((R)) Circo+MH RTU vaccine in swine reared in field condition in Italian swine production

To evaluate the safety of the administration of Suvaxyn((R)) Circo+MH RTU vaccine in piglets, a blinded, randomised, controlled clinical trial was carried out. The study was conducted, according to Good Clinical Practices (VICH-GL9/GCP) on 210 commercial hybrid piglets of 28 days of age; 71 animals were assigned to group 1 (G1, Suvaxyn Circo+MH RTU (R)), 69 to group 2 (G2, Porcilis PCV M Hyo((R))) and 70 to group 3 (CG, NaCl 0.9%). Four hours following vaccination and on days 1, 2, 3, 4, 7 e 14, animals were physically examined. Four hours following vaccination, animals in groups G1 (39.7 degrees) and G2 (40.2 degrees) showed an average rectal temperature significantly higher than the animals of control group (CG 39.5 degrees) and a significant difference (p<0.0001) was observed between G1 and G2. In G2 the temperature remained higher than CG, also the day following vaccination. Four hours following vaccination the percentage of animals with rectal temperature >= 40 degrees C was higher in G2 (63.8%) when compared to G1 (29.6%) and in both groups it was higher than CG (8.6%). On day 1 the percentage of animals with rectal temperature >= 40 degrees C in G2 (30.4%) was higher than in G1 (19.7%) and CG (14.3%). Local reactions were mild and resulted in a small, painless bump (<= 0.5 cm diameter) and recovered in 24 hours except in one piglet in G2 where the lesion disappeared on day 2. The percentage of animals showing injection site reactions in G2 (7.2% and 5.8% respectively) was higher than CG (0% and 0% respectively) four hours following vaccination and on day 1, while no significant differences were recorded for G1 (1.4% and 2.8% respectively) animals. Suvaxyn Circo+MH RTU (R) showed a good local and general safety inducing a mild and transient increase of rectal temperature and a lower number of injection site reactions when compared with the reference product.