In
a clinical trial
Nearly all children achieved a protective level of VZV
antibody post-dose 2.a
aA 6-week postvaccination
of VZV antibody level of >5 gpELISA units/mL is regarded
as an
approximate correlate of protection.3
VZV=varicella-zoster virus.
- 2,216 children 12 months to 12 years of age with a negative
history of varicella were randomized to receive either
1 dose of VARIVAX or 2 doses given 3 months apart. Subjects
were followed on an annual basis for 10 years after vaccination.
— Percentage
of patients achieving seroprotection after receiving
1 dose in the 1-dose regimen was 84.9%.
Select Safety Information
VARIVAX is contraindicated in certain individuals, including those with: a
history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactoid
reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or
other malignant neoplasms affecting the bone marrow or lymphatic systems; an
immunodeficient condition or receiving immunosuppressive therapy; active, untreated
tuberculosis; active febrile illness; or those who are pregnant.
In children, adolescents, and adults monitored for up to 42 days, the adverse
effects most frequently reported were as follows: fever, injection-site complaints,
varicella-like rash (injection site), and varicella-like rash (generalized).
The duration of protection of VARIVAX is unknown; however, long-term efficacy
studies have demonstrated continued protection up to 10 years after vaccination.
Vaccination with VARIVAX may not result in protection of all healthy, susceptible
children, adolescents, and adults.
Before administering VARIVAX, please read the Prescribing
Information and
Patient
Product Information.
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