Initial U.S. Approval: 2005
ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella [chickenpox]…
Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus.
Avoid using salicylates for 6 weeks after vaccination with ProQuad.
[T]ransmission of varicella vaccine virus… resulting in varicella infection… may occur between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.
Vaccine recipients should attempt to avoid, to the extent possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination.
Excretion of small amounts of the live, attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
[F]ever and measles-like rash usually occurred within 5 to 12 days following the vaccination…
Post-Marketing Experience
– Subacute sclerosing panencephalitis, encephalitis, aseptic meningitis, meningitis, measles, atypical measles, pneumonia, respiratory infection, infection, varicella (vaccine strain), influenza, herpes zoster, orchitis, epididymitis, cellulitis, skin infection, retinitis, bronchitis, parotitis [mumps], sinusitis, impetigo, herpes simplex, candidiasis, rhinitis.
– The vaccine virus (Oka/Merck strain) contained in ProQuad may establish latency of varicella zoster virus in immunocompetent individuals, with the potential for later development of herpes zoster.
– Cases of encephalitis or meningitis caused by vaccine strain varicella virus have been reported in immunocompetent individuals previously vaccinated with VARIVAX (same varicella vaccine strain as in ProQuad) months to years after vaccination. Reported cases were commonly associated with preceding or concurrent herpes zoster rash.
– Aplastic anemia, thrombocytopenia, regional lymphadenopathy, lymphadenitis.
– Anaphylaxis and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, anaphylactoid reaction.
– Agitation, apathy, nervousness.
– Measles inclusion body encephalitis, acute disseminated encephalomyelitis, transverse myelitis, cerebrovascular accident, encephalopathy, Guillain-Barré syndrome, optic neuritis, Bell’s palsy, polyneuropathy, ataxia, hypersomnia, afebrile convulsions or seizures, febrile seizure, headache, syncope, dizziness, tremor, paresthesia.
– Necrotizing retinitis (in immunocompromised individuals), retrobulbar neuritis, ocular palsies, edema of the eyelid, irritation eye.
– Nerve deafness, ear pain.
– Extravasation blood.
– Pneumonitis, pulmonary congestion, wheezing, bronchial spasm, epistaxis, sore throat.
– Hematochezia, abdominal pain, mouth ulcer.
– Stevens-Johnson syndrome, Henoch-Schönlein purpura, erythema multiforme, acute hemorrhagic edema of infancy, purpura, skin induration, panniculitis, pruritus.
– Arthritis, arthralgia, pain of the hip, leg, or neck; myalgia; musculoskeletal pain.
– Injection-site complaints including wheal and flare, warm to touch, stiffness, warm sensation, inflammation, injection-site hemorrhage, injection-site injury.
[There was a t]wo-fold increase in the risk of febrile seizures in the same 5 to 12 day timeframe [compared with MMR and VARIVAX administered concomitantly]…
Rubella Virus… propagated in WI-38 human diploid lung fibroblasts…
Varicella Virus… propagated in MRC-5 cells…
…each 0.5-mL dose of the vaccine also contains… recombinant human albumin… MRC-5 cells including DNA and protein… bovine calf serum…
ProQuad has not been evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility.