Fel-O-Vax Giardia (Canada)

Giardia Lamblia Vaccine

Killed Protozoa

For Veterinary Use Only

Fel-O-Vax Giardia Indications

This product is for vaccination of healthy cats, 8 weeks of age or older, as an aid in the prevention of clinical disease and reduction in duration of shedding caused by Giardia lamblia infection.

Administration And Dosage

Dosage: Cats, inject one 1 mL dose subcutaneously using aseptic technique. Administer a second 1 mL dose 2 to 4 weeks after the first dose. Annual revaccination is recommended.

The role that the cat assumes in giardiasis in human beings is not known. Fel-O-Vax Giardia has been proven to prevent clinical disease caused by Giardia lamblia infection in cats and to significantly reduce the duration of cyst shedding. Subsequent to Giardia lamblia exposure, some vaccinates may shed, therefore, proper hygiene and sanitation practices should be implemented.

We do not have data to demonstrate the risk with respect to concurrent administration of other feline vaccines.

Fel-O-Vax Giardia Caution

Store in the dark at 2° to 7°C (35° to 45°F). AVOID FREEZING. SHAKE WELL. In case of anaphylactoid reaction, administer epinephrine.

Thimerosal and gentamicin added as preservatives.

Efficacy

One Year Duration Of Immunity Study

In a vaccination-challenge study, twenty cats, vaccinated at 8 weeks of age and then orally challenged with 10⁵ G. lamblia one year later, demonstrated significantly reduced clinical symptoms versus controls (n=10). Vaccinates demonstrated statistically significant reduction in the numbers of individuals with diarrhea, number of bowel movements per day and number of days of cyst-shedding. Ninety percent of vaccinates ceased fecal cyst shedding at 21 days post challenge. At necropsy, 42 days post challenge, vaccinates showed no evidence of trophozoite presence in small intestine samples whereas all controls were found to harbor the parasite. Based on the experimental challenge, the shedding of G. lamblia may occur in vaccinated cats, but the number of cats with diarrhea associated with G. lamblia infection will be significantly reduced.

It was concluded that vaccination with Fel-O-Vax Giardia, Giardia Lamblia Vaccine, Killed Protozoa, significantly reduced shedding in cats challenged one year post vaccination.

Efficacy Study In Immune Compromised Cats

Response to virulent challenge (10⁵) was evaluated 14 days post vaccination in 19 kittens receiving vaccine and 10 controls receiving placebo. All cats received two doses of vaccine or placebo, 3 weeks apart, and were treated with dexamethasone (0.22 mg/kg) concurrent with challenge at 14 days post vaccination, and continuing daily for 10 days.

Both frequency of fecal shedding and fecal cyst counts were significantly reduced in vaccinates. Whereas all control cats developed diarrhea, this symptom was present in only 2 of the 19 vaccinates (10%). The number of days with diarrhea was also significantly reduced in vaccinates. At necropsy, 21 days post challenge, all controls had trophozoites present in their intestinal sections. In contrast only 2 of the 19 vaccinates (10%) had trophozoites present.

This study demonstrated the efficacy of Fel-O-Vax Giardia, Giardia Lamblia Vaccine, Killed Protozoa, in protecting vaccinated cats from the clinical disease and infection caused by the experimental exposure to G. lamblia.

Field Safety

Study Summary

A total of 908 cats were enrolled at 12 trial sites with 888 cats receiving two doses and 20 cats receiving only one dose. The trial included 414 kittens at eight weeks of age or less.

During the two-week post vaccinal observation period after vaccination, no local or systemic adverse reactions were observed in 96.48% of the cats vaccinated. Thirty-four (34) reactions were reported in 32 cats. The total vaccine related incidence rate was 1.89% (34 in a total of 1,798 doses administered).

The most frequently reported reaction was site swelling with an incidence of 0.95%. One investigator at one site accounted for 94% of the total reported site-swelling reactions. In general, the swelling was first noted in these 16 kittens one to four days post vaccination and had resolved within three to nine days post vaccination. No kitten had this reaction after both the first and second vaccinations.

Other reactions that were reported included 12 cats with lethargy, ten of which were from a single owner (0.67%) and four cats with reactions categorized as other (0.28%). These consisted of local irritation, pain, or excess licking, erythema, and encrustation in the vicinity of the injection site. All reactions had resolved within one to two weeks of vaccination. Only one cat was reported to have mild reactions after both injections. All other reactions were reported after either the first injection or the second injection, but not after both injections. One hundred thirteen (113) non-vaccine related events and nine non-vaccine related mortalities were reported.

Conclusion

Results from this study demonstrated the safety of Fel-O-Vax Giardia, Giardia lamblia Vaccine, Killed Protozoa. Administration of this vaccine did not induce any severe local or systemic adverse reactions following more than 98.22% of the vaccinations administered. The reactions reported consisted of site swelling, lethargy, and local irritation at the injection site.

Manufactured by Fort Dodge Animal Health, Fort Dodge, Iowa 50501 USA

U.S. Vet. License No. 112

Distributed in Canada by Wyeth Animal Health, Division of Wyeth Canada, Guelph, Ontario, Canada

^® licensed user

C1330C

Nac No.