-
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 (Oka/Merck)] 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, M-M-R®II,
and VARIVAX are registered trademarks of Merck & Co.,
Inc.
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