INFORCE 3

Bovine Rhinotracheitis-Parainfluenza₃-Respiratory Syncytial Virus Vaccine

Modified Live Virus

For intranasal use only

This product has been shown to be effective for the vaccination of healthy cattle 3 days of age or older, including pregnant cows, against respiratory disease caused by infectious bovine rhinotracheitis (IBR) virus, parainfluenza3 (PI₃) virus and bovine respiratory syncytial virus (BRSV). A duration of at least 193 days has been demonstrated against IBR. Duration of immunity of the remaining fractions has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

Description

INFORCE 3 is a freeze-dried preparation of temperature-sensitive strains of IBR and PI₃ viruses and modified live BRSV, packaged with a sterile diluent for rehydration.

SAFETY AND EFFICACY:

In a safety study conducted with INFORCE 3, no significant adverse reactions related to vaccination were observed. Safety has been demonstrated in calves as young as 0 days of age, weaned calves, high stressed stockers, and pregnant cows in all 3 trimesters.

Efficacy of the BRSV fraction of INFORCE 3 was demonstrated in two vaccination-challenge studies (3- to 9-day-old calves and 6- to 8-week-old calves). Calves were administered either a single 2-mL dose in one nostril (3- to 9-day-old calves) or 1-mL doses in each nostril (6- to 8-week-old calves). One hundred percent (100%) of calves as young as 3 days of age, challenged at either 49- or 57-days post-vaccination (2 separate cohorts enrolled), as well as 100% of 6- to 8-week-old calves that were challenged 21 days post-vaccination, survived virulent BRSV challenge. Unvaccinated control calves in each study had 90% or 100% mortality after virulent BRSV challenge. For animals challenged 21 days after vaccination, the median proportion of lung lesions for vaccinated calves was only 2.5% compared to 46.8% in the control group.

Efficacy of the PI₃ fraction was also demonstrated in two vaccination-challenge studies conducted in 3- to 5-day-old calves (vaccinated with 2-mL dose in one nostril) and in 8-month-old weaned calves (vaccinated with 1-mL dose in each nostril).

Duration of Viral Shedding in Days (5 number-summary)

Study conducted in 3- to 5-day-old calves:

Study conducted in 8-month-old calves:

Short- and long-term efficacy of the IBR fraction was demonstrated in two vaccination-challenge studies. In the first study, 3- to 4-day-old calves were vaccinated with a single 2-mL dose via one nostril and challenged more than 6 months (193 days) later. Sixty five percent (65%) of control calves showed one or more clinical signs of acute IBR disease while only 15.8% of vaccinates were affected. In the second study, weaned 7- to 9-month-old calves vaccinated with 1-mL doses in each nostril were challenged 28 days after vaccination. All control calves (100%) showed symptoms of acute IBR disease while only 5% of the vaccinated calves were affected.

Directions For Use

General Directions: Aseptically rehydrate the freeze-dried vaccine with the sterile diluent provided, shake well, and administer 2 mL intranasally (IN) using a cannula or a syringe with the needle removed.

Primary Vaccination: Place the 2-mL dose in one nostril, or half the dose (1 mL) in each nostril. The presence of maternal antibody is known to interfere with the development of active immunity in cattle, and additional boosters will be required in most young animals.

For advice on revaccination frequency, consult your veterinarian or the manufacturer.

Precautions

Store at 2°-8°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

Use entire contents when first opened.

Sterilized syringes should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin as preservative.

Fetal health risks associated with the vaccination of pregnant animals with modified live vaccines cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with modified live vaccine use in pregnant animals should be discussed with a veterinarian.

As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

Do not mix with other products, except as specified above.

In case of human exposure, contact a physician.

Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471.

This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

For veterinary use only

VLN 190/PCN 1071.23

Zoetis Inc., Kalamazoo, MI 49007, USA

CPN: 3690261.4