Initial U.S. Approval: 2008
A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis…
Within the 31-day period following… KINRIX… serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis)… INFANRIX and inactivated poliovirus vaccine… serious adverse events (cellulitis, constipation, foreign body trauma, fever without identified etiology).
Postmarketing Experience
– Injection site vesicles.
– Syncope.
– Pruritus.
Additional adverse reactions reported following postmarketing use of INFANRIX, for which a causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid reactions, anaphylaxis, angioedema, and urticaria; apnea; collapse or shock-like state (hypotonic-hyporesponsive episode); convulsions (with or without fever); lymphadenopathy; and thrombocytopenia.
The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.
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.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.6 mg aluminum by assay) and 4.5 mg of sodium chloride.
KINRIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.