Indications for: KINRIX

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.

Clinical Trials:

Immunological Evaluation

  • The immunogenicity of Kinrix was evaluated in a US multicenter study (Study 048) which included 4209 children 4 through 6 years of age who previously received 4 doses of Infanrix, 3 doses of IPV, and 1 dose of MMR vaccine.

  • Patients were randomly assigned 3:1 to receive either Kinrix or Infanrix and IPV (Sanofi Pasteur SA) administered concomitantly at separate sites. Patients also received MMR vaccine (Merck & Co., Inc.) administered concomitantly at a separate site.

  • Levels of antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus antigens were measured in sera obtained immediately prior to vaccination and 1 month (range: 31 to 48 days) after vaccination. 

  • The co-primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month after vaccination.

  • Kinrix achieved noninferiority to Infanrix and IPV with regards to booster responses to DTaP antigens and post-vaccination GMTs for anti-poliovirus antibodies.

Concomitant Vaccine Administration 

  • The immune responses to the antigens contained in Kinrix was evaluated in a US study (Study 055) that enrolled children aged 4 to 6 years. Patients received Kinrix concomitantly at separate sites with MMR vaccine (Merck & Co., Inc.) (n=237) or with MMR vaccine and varicella vaccine (Merck & Co., Inc.) (n = 239).

  • Immune responses to the antigens contained in Kinrix were measured approximately 1 month (28 to 48 days) after vaccination.

  • Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) after the receipt of Kinrix administered concomitantly with MMR vaccine and varicella vaccine were non-inferior to immune responses following concomitant administration of Kinrix administered with MMR vaccine.

Adult Dosage:

Not applicable.

Children Dosage:

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

KINRIX Contraindications:

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, progressive encephalopathy).

KINRIX Warnings/Precautions:

Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may give antipyretics. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable.

KINRIX Classification:


KINRIX Interactions:

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

Adverse Reactions:

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


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 Tip-Lok syringes—5 (without needles)