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This video is for instructional purposes only. The vaccine and diluent vials
shown in this video may differ in appearance from actual vials of ProQuad and/or
its accompanying diluent.
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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 (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 512 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 030
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. |