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ProQuad is indicated for simultaneous
vaccination against measles, mumps, rubella, and varicella
in children 12 months through 12 years of age. ProQuad
may be used in children 12 months through 12 years
of age if a 2nd dose of measles, mumps, and rubella
vaccine is to be administered.
— At least 1 month should elapse between a dose of a measles-containing
vaccine such as
 M-M-R®II (Measles,
Mumps, and Rubella Virus Vaccine Live) and a dose of ProQuad.
— If for any reason a second dose of varicella-containing vaccine is required,
at least 3 months
should
elapse between administration of the 2 doses.
Select Safety Information
ProQuad should not be administered to certain individuals,
including those with any of the following: a history
of anaphylactic reactions to neomycin; a history of
hypersensitivity to gelatin or any other component
of the vaccine; blood dyscrasias, leukemia, lymphomas
of any type, or other malignant neoplasms affecting
the bone marrow or lymphatic system; an immunodeficient
condition or receiving immunosuppressive therapy; active
untreated tuberculosis; an active febrile illness (>101.3°F);
or those who are pregnant.
In clinical trials with ProQuad involving children
12 to 23 months of age, the most frequently reported
injection-site adverse experiences (>1% of
children) were pain/tenderness/soreness, erythema,
swelling, ecchymosis, and rash. The most frequently
reported systemic vaccine-related adverse experiences
(>1% of children) were fever (>102°F),
irritability, measles-like rash, varicella-like rash,
rash (not otherwise specified), upper respiratory infection,
viral exanthema, and diarrhea.
In these trials, the only systemic vaccine-related
adverse experiences that were reported at a significantly
greater rate in individuals who received ProQuad than
in individuals who received M-M-R®II and
VARIVAX® (Varicella Virus Vaccine Live)
were fever (>102°F [>38.9°C]
oral equivalent or abnormal) (21.5% versus 14.9%, respectively),
and measles-like rash (3.0% versus 2.1%, respectively).
Febrile seizures have been reported in children receiving
ProQuad. Consistent with clinical study data on the
timing of fever and measles-like rash, an interim analysis
of a postmarketing observational study in children
(N = 14,263) receiving their first dose of vaccine
has shown that febrile seizures occurred more frequently
5–12 days following vaccination with ProQuad (0.5
per 1000) when compared with data from children in
a historical, age- and gender-matched, control group
vaccinated with M-M-R®II and
VARIVAX (N = 14,263) concomitantly (0.2 per 1000).
In the 0–30 day time period following vaccination,
the incidence of febrile seizures with ProQuad (1.0
per 1000) was not greater than that observed in children
receiving M-M-R®II and VARIVAX
concomitantly (1.3 per 1000).
The duration of protection from measles, mumps, rubella,
and varicella infections after vaccination with ProQuad
is unknown.
Vaccination with ProQuad may not offer 100% protection
from measles, mumps, rubella, and varicella infection.
Before administering ProQuad, please read the Prescribing
Information
ProQuad is a registered trademark of Merck & Co.,
Inc.
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