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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 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.
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| Select Safety Information |
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- 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 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.
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Helps protect with
immunogenicity similar to that of M-M-R®II (Measles,
Mumps,
and Rubella Virus Vaccine Live) and VARIVAX® [Varicella
Virus Vaccine Live (Oka/Merck)] |
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First-dose
immune response rates with ProQuad administered
to children 12 to 23 months of agea
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aN=5,446 healthy
children
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These results were
similar to the immune response rates induced
by concomitant administration of M-M-R®II and VARIVAX at separate injection sites. |
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Efficacy
of measles, mumps, rubella, and varicella components
was previously established in a series of clinical
studies with the monovalent vaccines; a high
degree of protection from infection was demonstrated
in these studies.
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| Formal
studies to evaluate the efficacy of ProQuad have
not been performed. |
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| Demonstrated coverage—High
antibody persistence 1 year after a single vaccination |
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| Long-term antibody
persistence has been previously established with measles,
mumps, rubella, and varicella components. |
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- Experience with M-M-R®II demonstrates
that antibodies to measles, mumps, and rubella
are still detectable in most individuals 11 to
13 years after primary vaccination.
- Varicella antibodies were present for up to 10
years postvaccination in most of the individuals
tested who received 1 dose of VARIVAX.
- The duration of protection from measles, mumps,
rubella, and varicella infections after vaccination
with ProQuad is unknown.
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No clinical data are available on the safety,
immunogenicity, and efficacy of ProQuad in children
less than 12 months of age.
The safety and efficacy of ProQuad for use after
exposure to measles, mumps, rubella, or varicella
have not been established.
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