Initial U.S. Approval: 2002
PEDIARIX is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis.
Serious Adverse Events
Within 30 days… pyrexia, gastroenteritis… culture-negative clinical sepsis… uteropelvic junction obstruction… testicular atrophy… bronchiolitis.
Deaths
In 14 clinical trials, 5 deaths were reported among 8,088 (0.06%) recipients of PEDIARIX and 1 death was reported among 2,287 (0.04%) recipients of comparator vaccines. Causes of death in the group that received PEDIARIX included 2 cases of Sudden Infant Death Syndrome (SIDS) and 1 case of each of the following: convulsive disorder, congenital immunodeficiency with sepsis, and neuroblastoma. One case of SIDS was reported in the comparator group.
Onset of Chronic Illnesses
(3%) who received PEDIARIX and… (4%) who received INFANRIX, ENGERIX-B, and IPV reported new onset of a chronic illness...
Postmarketing Spontaneous Reports for PEDIARIX
– Cyanosis.
– Diarrhea, vomiting.
– Fatigue, injection site cellulitis, injection site induration, injection site itching, injection site nodule/lump, injection site reaction, injection site vesicles, injection site warmth, limb pain, limb swelling.
– Anaphylactic reaction, anaphylactoid reaction, hypersensitivity.
– Upper respiratory tract infection.
– Abnormal liver function tests.
– Bulging fontanelle, depressed level of consciousness, encephalitis, hypotonia, hypotonic-hyporesponsive episode, lethargy, somnolence, syncope.
– Crying, insomnia, nervousness, restlessness, screaming, unusual crying.
– Apnea, cough, dyspnea.
– Skin and Subcutaneous Tissue Disorders Angioedema, erythema, rash, urticaria.
– Pallor, petechiae.
Postmarketing Spontaneous Reports for INFANRIX and/or ENGERIX-B
– Idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia.
– Abdominal pain, intussusception, nausea.
– Asthenia, malaise.
– Jaundice
– Anaphylactic shock, serum sickness–like disease.
– Arthralgia, arthritis, muscular weakness, myalgia.
– Encephalopathy, headache, meningitis, neuritis, neuropathy, paralysis.
– Alopecia, erythema multiforme, lichen planus, pruritus, Stevens Johnson syndrome.
– Vasculitis
The diphtheria, tetanus, and pertussis components are the same as those in INFANRIX and KINRIX. The hepatitis B surface antigen is the same as that in ENGERIX-B.
The diphtheria toxin is produced… in Fenton medium containing a bovine extract. Tetanus toxin is produced… in a modified Latham medium derived from bovine casein.
The inactivated poliovirus component is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells…
Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture.
Diphtheria and tetanus toxoids and pertussis antigens… are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate.
Each 0.5-mL dose contains aluminum salts as adjuvant… 0.85 mg aluminum.
PEDIARIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.