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Table 1 presents the results of injection site reaction observations from the safety study conducted in pre-breeding gilts. Similar results were obtained in two other field safety studies involving gestating sows and gilts. Of 205 vaccinated pre-breeding gilts, only one showed a clinically relevant injection site reaction immediately after vaccination and it was resolved within one day. Only a single injection site reaction was observed with the 202 revaccinated pre-breeding gilts and it was resolved after four days. No other clinical observations (off feed, lameness, etc.) were attributed to vaccination.
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*Injection site score 3 (> 5 cm) on Days 1, 2, or 3 after vaccination.
No injection site reactions were observed by the Investigator on Days 10 or 35, or by
the farm staff on any of the other study days.
†Two animals were unsuitable for continuing on the study for health reasons unrelated
to vaccination and were removed by the Investigator. One additional gilt was revaccinated with the incorrect serial, and the data after revaccination were not included in the summary and
analysis.
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