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The vaccine component of VANGUARD® Plus 5/L contains attenuated strains of
CD virus, CAV-2, CPI virus, and CPV propagated on an established canine cell line.
The CPV fraction is high titer (107.0 TCID50/dose) and was attenuated by low passage
(35 passes from the canine isolate with a maximum of 2 additional passes allowed
for production) on the canine cell line which gives it the immunogenic properties
capable of overriding maternal antibody interference at the levels indicated in
Table 2. Some puppies in the field may have higher levels of maternal antibodies
than those evaluated in our pivotal efficacy study. The vaccine is packaged in
freeze-dried form with inert gas in place of vacuum. The bacterin component, containing
inactivated whole cultures of L. canicola and L. icterohaemorrhagiae, is supplied
Contains penicillin and streptomycin as preservatives.
Indications: VANGUARD® Plus 5/L is for vaccination of healthy dogs
6 weeks of age or older as an aid in preventing canine distemper caused by canine
distemper (CD) virus, infectious canine hepatitis (ICH) caused by canine adenovirus
type 1 (CAV-1), respiratory disease caused by canine adenovirus type 2 (CAV-2),
canine parainfluenza caused by canine parainfluenza (CPI) virus, canine parvoviral
enteritis caused by canine parvovirus (CPV), and leptospirosis caused by Leptospira
canicola and L. icterohaemorrhagiae.
1. General Directions: Vaccination of healthy dogs is recommended. Aseptically
rehydrate the freeze-dried vaccine (VANGUARD® Plus 5) with the liquid bacterin
provided (Leptoferm C-I®), shake well, and administer 1 mL subcutaneously
2. Primary Vaccination: Healthy dogs 6 weeks of age or older should receive
3 doses, each administered 3 weeks apart.
3. Revaccination: Annual revaccination with a single dose is recommended.
Precaution(s): Store at 2°-7°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 and needles should be used to administer this vaccine.
Do not sterilize with chemicals because traces of disinfectant may inactivate
Burn containers and all unused contents.
Caution(s): Vaccination of pregnant bitches should be avoided.
As with many vaccines, anaphylaxis may occur after use. Initial antidote of
epinephrine is recommended and should be followed with appropriate supportive
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 use in dogs only.
Warning(s): For veterinary use only.
Disease Description: CD is a universal, high-mortality viral disease with variable
manifestations. Approximately 50% of nonvaccinated, nonimmune dogs infected
with CD virus develop clinical signs, and approximately 90% of those dogs die.1
ICH, caused by CAV-1, is a universal, sometimes fatal, viral disease of dogs
characterized by hepatic and generalized endothelial lesions. CAV-2 causes respiratory
disease which in severe cases may include pneumonia and bronchopneumonia. CPI
is a common viral upper respiratory disease. Uncomplicated CPI may be mild or
subclinical, with signs becoming more severe if concurrent infection with other
respiratory pathogens exists. CPV infection results in enteric disease characterized
by sudden onset of vomiting and diarrhea, often hemorrhagic. Leukopenia commonly
accompanies clinical signs. Susceptible dogs of any age can be affected, but
mortality is greatest in puppies. In puppies 4-12 weeks of age CPV may occasionally
cause myocarditis that can result in acute heart failure after a brief and inconspicuous
illness. Following infection many dogs are refractory to the disease for a year
or more. Similarly, seropositive bitches may transfer to their puppies CPV antibodies
which can interfere with active immunization of the puppies through 16 weeks
of age. Leptospirosis occurs in dogs of all ages, with a wide range of clinical
signs and chronic nephritis generally following acute infection. Infection with
L. canicola and L. icterohaemorrhagiae cannot be differentiated clinically.
Trial Data: Safety and Efficacy: Laboratory evaluation demonstrated
that VANGUARD® Plus 5/L immunized dogs against CD, ICH, CAV-2 respiratory
disease, CPI, CPV, and leptospirosis caused by L. canicola and L. icterohaemorrhagiae,
and that no immunologic interference existed among the vaccine fractions. Extensive
field safety trials conducted by Pfizer Animal Health showed it to be safe and
reaction-free in dogs as young as 6 weeks of age under normal usage conditions.
It has been demonstrated that CAV-2 vaccine cross-protects against ICH caused
by CAV-1. The CAV-2 fraction in Vanguard® vaccines is used as a replacement
for CAV-1 because it has significant advantages. Some CAV-1 vaccines may produce
undesirable reactions, including persistent kidney infections, uveitis, and
corneal opacity ("blue eye"), which have not been reported after vaccination
with CAV-2.2 In addition, the CAV-2 strain used in Vanguard® vaccines has
been specially selected for freedom from oncogenic properties characteristic
Studies conducted at Pfizer demonstrated that CAV-2 not only protects against
ICH, but against CAV-2 respiratory disease as well.3 Although conventional CAV-1
(ICH) vaccines cross-protect against CAV-2, they may not prevent subclinical
infection and spread of the CAV-2 agent. Canine adenovirus type 2 challenge
virus was not recovered from CAV-2-vaccinated dogs in tests conducted at Pfizer