Initial U.S. Approval: 2015
Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.
ADVERSE REACTIONS
In a clinical study, the most common solicited injection site reactions were pain (>75%), increase in arm circumference (>65%), erythema (>55%), and swelling (>40%). Common solicited systemic reactions were myalgia (>50%), malaise (>35%), and headache (>15%).
Postmarketing Experience
– Anaphylactic reaction, hypersensitivity and allergic reactions (such as rash, urticaria, dyspnea)
– Screaming
– Somnolence, convulsion, febrile convulsion, HHE, hypotonia
– Cyanosis
– Pallor
– Listlessness
– Injection site reactions (including inflammation, mass, sterile abscess, and edema)
– Large injection site reactions (>50 mm), including limb swelling which may extend from the injection site beyond one or both joints
– Injection site cellulitis, injection site abscess
Poliovirus Type 1, Type 2 and Type 3 are each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells…
The cells are grown in… 1969 medium, supplemented with calf serum.
Each 0.5 mL dose contains 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant…
Quadracel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.