1.  Centers for Disease Control and Prevention (CDC). Use of combination measles, mumps, rubella, and varicella vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59(RR-3):1–12.
2.  Centers for Disease Control and Prevention (CDC). Home. Vaccines for Children Program (VFC)
Web site. http://www.cdc.gov/vaccines/programs/
vfc/index.html. Updated April 24, 2014. Accessed
March 2, 2016.
3.  Centers for Disease Control and Prevention (CDC).
About VFC. Vaccines for Children Program (VFC)
Web site. http://www.cdc.gov/vaccines/programs/
vfc/about/index.html. Updated February 14, 2014. Accessed March 2, 2016.
4.  Centers for Disease Control and Prevention (CDC). VFC Detailed Questions and Answers for Parents. Vaccines for Children Program (VFC) Web site. http://www.cdc.gov/vaccines/programs/vfc/parents/
qa-detailed.html. Updated February 19, 2013. Accessed March 2, 2016.

Indication

ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

Selected Safety Information for ProQuad® (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)

ProQuad is contraindicated in individuals with any of the following: history of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine; primary or acquired immunodeficiency states; family history of congenital or hereditary immunodeficiency; immunosuppressive therapy; active untreated tuberculosis or febrile illness (>101.3°F or >38.5°C); or those who are pregnant.

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) administered separately.

Use caution when administering ProQuad to children with: a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; contact hypersensitivity to neomycin; thrombocytopenia.

Advise vaccinees to avoid: close contact with high-risk individuals susceptible to varicella; pregnancy for 3 months after vaccination; using salicylates for 6 weeks after vaccination. Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).

The most frequent vaccine-related adverse events reported in ≥5% of subjects vaccinated with ProQuad were: injection-site reactions (pain/tenderness/soreness, erythema, and swelling); fever; and irritability. Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash.

Before administering ProQuad® (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), please read the Prescribing Information.

Frequently Asked Questions

Is ProQuad recommended by the ACIP?

Yes. The ACIP generally prefers ProQuad for the routine 2nd dose at any age between 15 months and 12 years. For the routine 1st dose at 12 to 15 months of age, the ACIP recommends that M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), and VARIVAX® (Varicella Virus Vaccine Live) be administered as separate injections, unless the parent/caregiver expresses a preference for ProQuad.1

For more information on the ACIP recommendations, click here.

ACIP=Advisory Committee on Immunization Practices.

Is there a risk of febrile seizures associated with ProQuad?

ProQuad is associated with a higher relative risk of febrile seizures at 5 to 12 days after vaccination compared with M-M-R®II and VARIVAX administered concomitantly. In a postmarketing observational safety surveillance study in children 12 to 60 months of age (N=31,298, of which 31,043 were 12 to 23 months old), the incidence of febrile seizures 5 to 12 days after ProQuad administered at Dose 1 (0.70 per 1,000 children) was higher than that in children (N=31,298, of which 31,019 were 12 to 23 months old) receiving M-M-R®II and VARIVAX concomitantly (0.32 per 1,000 children) [RR 2.20 (95% CI: 1.04, 4.65)].

In this postmarketing observational study, no cases of febrile seizure were observed during the 5- to 12- day postvaccination period among children (n=26,455) who received ProQuad as a 2nd dose.

CI=confidence interval; RR=relative risk.

What were the immune response rates in clinical trials with ProQuad?

In the clinical trials of children aged 12 to 23 months and 4 to 6 years, ProQuad demonstrated the following immune response rates after the 1st and 2nd dose.

1st-dosea and 2nd-doseb observed immune response rates for ProQuad
Measles Mumps Rubella Varicella
1st Dose
12 to 23 months of age
97.4% 95.8%
and
98.8%c
98.5% 91.2%
2nd Dose
4 to 6 years of age
100% 99.5% 100% 98.9%

These results were similar to the immune response rates induced by the concomitant administration of
M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) at separate injection sites.

The efficacy of the measles, mumps, rubella, and varicella components of ProQuad 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.

Formal studies to evaluate the clinical efficacy of ProQuad have not been performed.

a N=5,446 healthy children 6 weeks after receiving a single dose of ProQuad.

b N=399 healthy children 6 weeks after receiving a single dose of ProQuad; children received primary vaccination with M-M-R®II and VARIVAX at least 1 month prior to study entry.

c The mumps antibody response after the 1st dose was assessed using 2 different enzyme-linked immunosorbent assays (ELISA) in separate, randomized clinical studies: a vaccine-strain ELISA and a wild-type ELISA.

Is ProQuad covered by the Vaccines for Children (VFC) Program?

Yes, ProQuad is covered by the VFC Program, a federally funded program that provides vaccines at no cost to children whose parents or guardians may not be able to afford them.2-4

For more information, contact your State Immunization Coordinator. For a complete list of products covered by the VFC Program, click here.

See Indication and Selected Safety Information for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) below.

About ProQuad

ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

Each 0.5 mL dose of ProQuad is administered subcutaneously.

  • The first dose is usually administered at 12 to 15 months of age.
  • A second dose, if needed, is usually administered at 4 to 6 years of age.

Selected Safety Information for ProQuad

ProQuad is contraindicated in individuals with any of the following: history of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine; primary or acquired immunodeficiency states; family history of congenital or hereditary immunodeficiency; immunosuppressive therapy; active untreated tuberculosis or febrile illness (>101.3°F or >38.5°C); or those who are pregnant.

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R®II and VARIVAX administered separately.

Use caution when administering ProQuad to children with: a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; contact hypersensitivity to neomycin; thrombocytopenia.

Advise vaccinees to avoid: close contact with high-risk individuals susceptible to varicella; pregnancy for 3 months after vaccination; using salicylates for 6 weeks after vaccination. Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).

The most frequent vaccine-related adverse events reported in ≥5% of subjects vaccinated with ProQuad were: injection-site reactions (pain/tenderness/soreness, erythema, and swelling); fever; and irritability. Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash.

Before administering ProQuad® (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), please read the accompanying Prescribing Information.

About M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

M-M-R®II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

The ACIP recommends administration of the first dose of M-M-R®II at 12 to 15 months of age and administration of the second dose of M-M-R®II at 4 to 6 years of age.

Selected Safety Information for M-M-R®II

M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic or 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; an active febrile illness; or those who are pregnant.

Due caution should be employed in administration of M-M-R®II to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided.

The following adverse reactions have been reported with M-M-R®II without regard to causality: fever, headache, dizziness, rash, injection-site reactions, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, and thrombocytopenia.

As for any vaccine, vaccination with M-M-R®II may not result in protection in 100% of vaccinees.

Before administering M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

About VARIVAX® (Varicella Virus Vaccine Live)

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.

Each dose is approximately 0.5 mL after reconstitution and is administered by subcutaneous injection.

Children (12 months to 12 years of age): If a second dose is administered, there should be a minimum interval of 3 months between doses.

Adolescents (≥13 years of age) and Adults: 2 doses, to be administered with a minimum interval of 4 weeks between doses.

Selected Safety Information for VARIVAX

Do not administer VARIVAX to individuals with: a history of severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of varicella vaccine; immunosuppressed or immunodeficient individuals, including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma, or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS, or receiving immunosuppressive therapy; any febrile illness or active infection, untreated tuberculosis; or those who are pregnant.

Evaluate individuals for immune competence prior to administration of VARIVAX if there is a family history of immunodeficiency. Vaccine recipients should avoid contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Defer vaccination for ≥5 months following blood or plasma transfusions or administration of immune globulins. Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents.

Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years who were monitored for 42 days include: fever ≥102.0°F (38.9°C) oral: 14.7%; injection-site complaints: 19.3%. Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older monitored for up to 42 days include: fever ≥100.0°F (37.8°C) oral: 10.2%; injection-site complaints: 24.4%. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalized).

In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42 day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).

The duration of protection from varicella infection after vaccination with VARIVAX is unknown.

Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.

Before administering VARIVAX® (Varicella Virus Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

VACC-1175000-0002 02/17