Frequently Asked Questions about ProQuad

Indications

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.

The recommended dosing for ProQuad is a 0.5-mL dose of ProQuad administered subcutaneously.

The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age.

The second dose is administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

Selected Safety Information

• ProQuad is contraindicated in individuals with any of the following: history of hypersensitivity to any component of the vaccine (including gelatin) or to a previous dose of M-M-R^®_II (Measles, Mumps, and Rubella Virus Vaccine Live), ProQuad, or VARIVAX^® (Varicella Virus Vaccine Live) or any other measles, mumps, rubella, or varicella-containing vaccine; a history of anaphylaxis to neomycin; immunodeficiency or immunosuppression; or moderate or severe febrile illness; active untreated tuberculosis; or those who are pregnant or who are planning on becoming pregnant in the next 3 months.
• 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 a first dose of M-M-R^®_II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX^® (Varicella Virus Vaccine Live) administered concomitantly. Exercise caution when administering ProQuad to persons with an individual or family history of febrile seizures.
• Use caution when administering ProQuad to individuals with: anaphylaxis, anaphylactoid, or immediate hypersensitivity to eggs; thrombocytopenia or to those who have experienced thrombocytopenia after vaccination with a previous dose of a measles, mumps, and rubella-containing vaccine.
• Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent.
• Advise vaccinees to avoid: close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts; pregnancy for 3 months after vaccination; using salicylates for 6 weeks after vaccination. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals.
• Immune globulins (IG) and other blood products should not be given concurrently with ProQuad. These products may contain antibodies that interfere with vaccine virus replication and decrease the expected immune response.
• Avoid the use of salicylates or salicylate-containing products in children and adolescents 12 months through 12 years of age, for six weeks following vaccination with ProQuad due to the association of Reye syndrome with salicylate therapy and wild-type varicella infection.
• 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. In children 12 to 23 months of age, the only vaccine-related injection-site adverse reaction that was more frequent among recipients of ProQuad than recipients of M-M-R^®_II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX^® (Varicella Virus Vaccine Live) was rash at the injection site (2.4% versus 1.6%, respectively).
• Before administering ProQuad, please read the accompanying Prescribing Information.

Dosage and Administration

• Each 0.5 mL dose of ProQuad is administered subcutaneously.
  • The first dose is administered at 12 to 15 months of age.
  • The second dose is administered at 4 to 6 years of age.

• At least 1 month should elapse between a measles-containing product and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.
• In immunocompromised individuals who have been inadvertently vaccinated with: measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported; mumps and rubella-containing vaccine, disseminated mumps and rubella vaccine virus infection have been reported; or varicella-containing vaccine, disseminated varicella disease and extensive vaccine-associated rash have been reported.
• Tuberculin testing should be administered any time before, simultaneously with, or at least 4 to 6 weeks after ProQuad.
• ProQuad may be administered concomitantly with Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine.
• ProQuad may be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites.
• The duration of protection from measles, mumps, rubella, and varicella infections after vaccination with ProQuad is unknown.

Before administering ProQuad, please read the Prescribing Information. The Patient Information also is available.

Each 0.5-mL dose of ProQuad is administered subcutaneously. The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. 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. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

The CPT Code for ProQuad is 90710.

Storage Temperature Range

To maintain potency, ProQuad must be stored frozen between -58°F and +5°F (-50°C to -15°C). Use of dry ice may subject ProQuad to temperatures colder than -58°F (-50°C).

Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between −58°F and +5°F (−50°C and −15°C) for up to 18 months. Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature between −58°F and +5°F (−50°C and −15°C) and has a separate sealed freezer door is acceptable for storing ProQuad. Routine defrost cycling of a frost-free freezer is acceptable.

Temperature Range Prior to Reconstitution

ProQuad may be stored at refrigerator temperature (36° to 46°F, 2° to 8°C) for up to 72 hours prior to reconstitution. Discard any ProQuad vaccine stored at 36° to 46°F which is not used within 72 hours of removal from 5°F (-15°C) storage.

Light Exposure

Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.

Guidelines for Reconstituted Vaccine

• IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES.
• DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
• DO NOT FREEZE RECONSTITUTED VACCINE.

Diluent Storage Temperature

Diluent should be stored separately at room temperature (68° to 77°F, 20° to 25°C), or in a refrigerator (36° to 46°F, 2° to 8°C).

For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90.

For more information on vaccine storage and handling, please visit www.vaccinestorageandhandling.com to review the guidelines and help ensure your practice’s compliance.

The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age.

The second dose is administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and 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.

For the first dose of the MMRV vaccine at 12-47 months of age, the CDC recommends separate doses of MMR and varicella vaccines, unless the parent or caregiver expresses a preference for MMRV vaccine.

For the second dose of an MMRV vaccine, the CDC generally prefers the combination vaccine MMRV over separate injections of its equivalent component vaccines (i.e., MMR vaccine and varicella vaccine).

The CDC Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger specifies routine vaccination for measles, mumps, and rubella and varicella vaccination is a 2-dose series at 12–15 months, and 4–6 years. Dose 2 may be administered as early as 4 weeks after dose 1 of a measles-containing vaccine and 3 months after a varicella-containing vaccine. For the second dose at 4-6 years, the CDC recommends the use of combination MMRV for appropriate patients.

The CDC Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger specifies catch-up vaccination for measles, mumps, rubella and varicella is for unvaccinated children and adolescents to receive a 2-dose series.

ProQuad should be given at least 1 month after a dose of measles-containing vaccine and at least 3 months after a dose of varicella-containing vaccine.

The maximum age for use of MMRV is 12 years.

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
• 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
• measles-like rash

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

MMR vaccine is a vaccine that helps prevent measles, mumps and rubella.

MMRV vaccine is a vaccine that helps prevent measles, mumps, rubella, and varicella (chickenpox).

Yes, in most states, ProQuad is available through the Vaccines for Children (VFC) program for children who qualify. Check with your state or local VFC program to learn more about the specific products available to your practice.

ProQuad can be ordered via ordering.merckvaccines.com, by calling into the Merck Vaccines Customer Care line 877.VAX.MERCK (877.829.6372), or through your preferred wholesaler/distributor. For a list of Merck authorized distributors please go to Authorized distributors – Merck.com.