Product: Kinrix
Company: GlaxoSmithKline
Pharmacologic class: Vaccine (diphtheria, tetanus, and pertussis [DTaP] + inactivated polio vaccine [IPV])
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Active ingredients: Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; IPV; suspension for IM injection; preservative-free; may contain trace formaldehyde, neomycin, polymyxin B, polysorbate 80.
Indication: Immunization against diphtheria, tetanus, pertussis, and polio: As the fifth dose in the DTaP immunization series and the fourth dose in the IPV series in children aged 4-6 years (before seventh birthday) who previously received Infanrix (DTaP) and/or Pediarix (DTaP, hepatitis B, IPV) for the first three doses and
Infanrix for the fourth dose.
Pharmacology: Kinrix is a combination vaccine for children intended to provide protection against diphtheria, tetanus, pertussis, and polio in one injection. The DTaP components of Kinrix are the same as those in
Infanrix and Pediarix (also from GlaxoSmithKline), and the poliovirus component is the same as that in Pediarix.
Clinical trials: In a randomized, controlled study conducted in the United States, 3,156 children aged
4-6 years who were previously immunized with four doses of DTaP and three doses of trivalent inactivated poliovirus vaccine (IPOL) (from Sanofi Pasteur) were immunized with Kinrix. All children also were given the second dose of MMR II (from Merck) concomitantly administered at separate sites. The control group was given Infanrix and IPOL vaccines. Levels of antibodies to the DTaP and poliovirus antigens were measured in sera obtained immediately prior to immunization and one month after vaccination. Kinrix offered similar protection to its component vaccines given separately with a similar safety profile. It was noninferior to Infanrix and IPV given separately in terms of booster responses to DTaP antigens and post-vaccination antibody titers for antipolio antibodies.
Adults: Not applicable.
Children: <4 years or >7 years: not recommended. 4-6 years: One dose of 0.5 mL in deltoid muscle.
Contraindications: Anaphylaxis associated with previous diphtheria, tetanus, pertussis, or polio vaccine. Encephalopathy within seven days of previous pertussis vaccine. Progressive neurologic disorders (e.g., infantile spasms, uncontrolled epilepsy).
Precautions: Guillain-Barré syndrome within six weeks of previous tetanus vaccination. Fever (>105°F within 48 hours), persistent inconsolable crying (longer than three hours within 48 hours), shock (within 48 hours), or seizures (within three days) after previous pertussis vaccine: see literature. Seizure risk: may pretreat with antipyretic. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat. C): not applicable.
Interactions: May give with concomitant vaccines (e.g., measles, mumps, and rubella). Immunosuppressants (e.g., radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Adverse reactions: Injection-site pain, redness, local swelling, increase in arm circumference, drowsiness, fever, appetite loss.
Note: Report adverse events to VAERS at 800.822.7967 and to GlaxoSmithKline at 888.825.5249.
How supplied: Single-dose vials—10; Single-dose prefilled syringes—5 (without needles)
For more information, call 888.825.5249 or visit www.Kinrix.com.
