Company:

GlaxoSmithKline

Vaccine (DTaP + IPV)

Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; may contain trace formaldehyde, neomycin, polymixin B, polysorbate 80.

Immunization against diphtheria, tetanus, pertussis, and polio: As the 5th dose in the DTaP immunization series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4–6 years of age (before 7th birthday) who previously received Infanrix (DTaP) and/or Pediarix (DTaP, HB, IPV) for the first 3 doses and Infanrix for the 4th dose.

Kinrix is a combination vaccine for children intended to provide protection against diphtheria, tetanus, pertussis and polio in one injection. The diphtheria, tetanus, and pertussis components of Kinrix are the same as those in Infanrix and Pediarix (also from GSK), and the poliovirus component is the same as that in Pediarix.

In a randomized, controlled study conducted in the US, 3,156 children 4 to 6 years of age who were previously immunized with four doses of DTaP and 3 doses of IPOL (from Sanofi Pasteur) were immunized with Kinrix. All children also were given the 2nd 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 diphtheria, tetanus, pertussis 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 non-inferior to Infanrix and IPV given separately, in terms of booster responses to DTaP antigens and post-vaccination antibody titers for anti-polio antibodies.

Not applicable.

<4 years or ≥7 years: not recommended. 4–6 years: One dose of 0.5mL in deltoid muscle.

Anaphylaxis associated with previous diphtheria, tetanus, pertussis, or polio vaccine. Encephalopathy within 7 days of previous pertussis vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy).

Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or seizures (within 3 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.

May give with concomitant vaccines (eg, MMR). Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

Injection site pain, redness, local swelling, increase in arm circumference, drowsiness, fever, appetite loss.

Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

Single-dose vials—10
Single-dose prefilled syringes—5 (without needles)

7/18/08