Vaccines:

Indications for: PROQUAD

Measles, mumps, rubella, and varicella immunization.

Clinical Trials:

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

Efficacy of the measles, mumps, rubella, and varicella components of ProQuad was previously established in a series of clinical studies with the monovalent vaccines.

 

Immunogenicity in Children 12 Months to 6 Years of Age

  • 5 randomized clinical trials evaluated immunogenicity in 5845 healthy children 12 months to 6 years of age with a negative history of measles, mumps, rubella, and varicella.

  • ProQuad administered subcutaneously was found to have similar immunogenicity to its individual component vaccines (M-M-R II and Varivax)

Immunogenicity in Children 12 to 23 Months of Age After a Single Dose

  • 4 randomized clinical trials evaluated immunogenicity in 5446 healthy children 12 to 23 months of age who received ProQuad subcutaneously, and 2038 children who received M-M-R II and Varivax concomitantly at separate injection sites. The trials included patients with a negative clinical history, no known recent exposure, and no vaccination history for varicella, measles, mumps, and rubella.

  • ProQuad was found to have similar immunogenicity to the concomitant administration of single doses of M-M-R II and Varivax at separate injection sites.

Immunogenicity in Children 15 to 31 Months of Age After a Second Dose of ProQuad

  • A second dose of ProQuad administered subcutaneously approximately 3 to 9 months after the first dose of ProQuad was evaluated in a subgroup of 5446 children.

  • 2 doses of ProQuad administered at least 3 months apart elicited a positive antibody response to all 4 antigens in greater than 98% of patients.

  • The GMTs after the second dose increased approximately 2-fold for measles, mumps, and rubella, and approximately 41-fold for varicella.

Immunogenicity in Children 4 to 6 Years of Age Who Received a First Dose of ProQuad After Primary Vaccination With M-M-R II and Varivax

  • 799 healthy children 4 to 6 years of age who previously received M-M-R II and Varivax at least 1 month prior to study entry (at 12 months of age or older) were randomly assigned to receive:

    • ProQuad subcutaneously and placebo (n=399), 

    • M-M-R II and placebo concomitantly at separate injection sites (n=205), or

    • M-M-R II and Varivax concomitantly at separate injection sites (n=195).

  • The first dose of ProQuad administered after primary vaccination with M-M-R II and Varivax elicited a positive antibody response to all 4 antigens in greater than 98% of patients.

  • The GMTs after the first dose of ProQuad were similar to that observed after a second dose of M-M-R II and Varivax. The GMTs for measles, mumps, and rubella after the first dose of ProQuad were similar to that observed after a second dose of M-M-R II and placebo. 

Immunogenicity Following 2 Doses of ProQuad Administered Intramuscularly or Subcutaneously

  • An open-label clinical trial (NCT00402831) evaluated the immunogenicity of 2 doses of Proquad administered 30 days apart in 405 children 12 through 18 months of age given intramuscularly (IM; n=202) or subcutaneously (SC; n=203).

  • Seroresponse rates to measles, mumps, and varicella viruses after dose 1 were noninferior in the IM group vs the SC group.

  • Seroresponse rate to rubella virus narrowly missed meeting the criterion for noninferiority.

  • Antibody titers above the seroresponse thresholds for measles, mumps, rubella, and varicella viruses after dose 1 was achieved by 100%, 97.4%, 98.4%, and 98.6%, respectively, of children in the IM group and 97.3%, 91.3%, 100%, and 98.5%, respectively, in the SC group.

Adult Dosage:

Not recommended.

Children Dosage:

<12 months or ≥13yrs: not established. Each dose is 0.5mL. Give by SC or IM inj. First dose at 12–15 months of age (or anytime through 12yrs of age), second dose at 4–6yrs of age.

PROQUAD Contraindications:

Gelatin or neomycin hypersensitivity. Immunodeficient or immunosuppressed. Active untreated tuberculosis. Active febrile illness with fever >101.3°F. Pregnancy (or planning to be within the next 3 months).

PROQUAD Warnings/Precautions:

History of febrile seizures. Hypersensitivity to eggs. Thrombocytopenia, or history of. Defer vaccination if family history of congenital or hereditary immunodeficiency until immunocompetent. Avoid contact with high-risk individuals susceptible to varicella for 6 weeks after vaccination. Reye syndrome. HIV-infected children. Nursing mothers.

PROQUAD Classification:

MMR+Var.

PROQUAD Interactions:

Immunosuppressants (see Contraindications). Avoid salicylates for 6 weeks after vaccination. Avoid concomitant immune globulin, other blood products; may decrease the immune response (see ACIP recommendations). Separate dosing of measles-containing vaccine by 1 month. If 2nd dose of varicella-containing vaccine needed, separate by 3 months. Concomitant other vaccines: see full labeling. May interfere with tuberculin skin test.

Adverse Reactions:

Inj site reactions, fever, irritability, rash; others.

Note:

Report adverse events to VAERS by calling (800) 822-7967.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials—10 (w. diluent)