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Summary:

This study demonstrated that Onset™ IN, containing modified live virus infectious bovine rhinotracheitis (IBR), bovine virus diarrhea (BVD) Type 1 and Type 2, parainfluenza3 (PI3), bovine respiratory syncytial virus (BRSV), avirulent live cultures of Pasteurella multocida and Mannheimia haemolytica , when administered intranasally, is proven safe when used under field conditions.

Materials and Methods:

Vaccine: Two individual serials of Onset IN were utilized. The freeze-dried Onset IN was rehydrated with the accompanying sterile saline diluent.

Animals: Animals receiving the vaccine ranged in age from birth (0 days of age) to 1 year. Cattle represented both beef and dairy breeds and were purchased, housed, and vaccinated in one of three geographical regions: New York, Kansas, or Indiana .

Vaccinations: Cattle were vaccinated according to label directions, i.e. Onset IN was given via aseptic needle-free administration (IN) delivering an immunizing dose into one nostril. Control calves were given a saline placebo in a similar manner.

None of the cattle in these studies received any other treatment for at least two days prior to or seven days following administration of this product, nor were any other treatments administered in the general location utilized for this product. A treatment is defined as any intervention applied to an animal, surgical or medical, which potentially could cause adverse events or which might confuse observations for this experimental product.

Observations and recorded information:

Cattle were observed for systemic events such as vomiting, lethargy, inappetence and allergic-type responses; and localized injection site events such as swelling, redness, abscessing, etc. for up to seven days following the administration of the test articles.

Results and Discussion:

A total of 608 cattle were administered Onset IN by the intranasal route. There were a total of 177 controls that were administered saline diluent only by the intranasal route. These cattle were from three separate geographical regions representing multiple herds from each region. Both beef and dairy breeds were included. Vaccinations were distributed between two vaccine serials. No local reactions were documented. There were 1.0% and 4.5% systemic reactions in Onset IN and control calves, respectively, that were not attributed to the vaccine as classified by the attending veterinarians. These systemic reactions consisted of lethargy and inappetence and were associated with concurrent naturally occurring respiratory or enteric disease events at the location.

Table 1. Injection safety observations. Data represents the number of cattle vaccinated or administered saline control per study and the number of animals exhibiting a reactive event.

* Clinical observations classified as systemic reactions were related to incidental respiratory and/or enteric cases at one study site. Based upon the attending veterinarian’s opinion these disease events were unrelated to the administration of the test articles.

Individual Herd Summary:

Location #1 (New York):

There was a total of 204 dairy heifers given Onset IN intranasally and 51 commingled controls (intranasal saline). The animals were between the ages of 0 days and 1 year. There were a total of 98 calves at this study site that were between 0 and 10 days of age.

No systemic or local reactions were noted in either treatment group.

Location #2 (Kansas):

There was a total of 200 beef calves, comprised of both sexes given Onset IN intranasally and 50 commingled controls (intranasal saline). The animals were between the ages of 0 days and 4 months. There were a total of 167 calves in the study that were between 0 and 4 days of age. No systemic or local reactions were noted in either treatment group.

Location #3 (Indiana):

There was a total of 204 dairy heifers and bulls given Onset IN intranasally and 76 commingled controls (intranasal saline). The animals were between the ages of 0 days and 4 months. There were a total of 99 calves at this study site that were between 0 and 10 days of age. There were six systemic reactions in vaccinates and eight in the controls. Based on the clinical findings it was the determination of the attending veterinarian that the calf sickness consisting of respiratory and enteric disease events seen during the observation period was incidental and was not related to the vaccine. There were no local reactions noted in either treatment group.

Conclusion:

Based on these study results, Onset IN, containing modified live virus infectious bovine rhinotracheitis (IBR), bovine virus diarrhea (BVD) Type 1 and Type 2, parainfluenza3 (PI3), bovine respiratory syncytial virus (BRSV), avirulent live cultures of Pasteurellamultocida and Mannheimia haemolytica , when administered intranasally, is proven safe when used under field conditions.