Type: Combined Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Form: Suspension for injection
Manufacturer: Sanofi Pasteur Limited
Indications and Clinical Use
Indication: Primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis for infants from 2 months of age and children up to 6 years (prior to their 7th birthday).
Not Indicated For: Persons younger than 2 months or older than 7 years.
Contraindications
Hypersensitivity: Known systemic hypersensitivity reaction to any component of QUADRACEL® or a life-threatening reaction after previous administration of the vaccine or a vaccine containing similar components.
Neurological Disorders: Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause; progressive neurologic disorder including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.
Dosage and Administration
Primary Immunization Schedule:
4-dose series: 0.5 mL at 2, 4, 6, and 18 months of age.
Delayed Schedule: 3 doses 2 months apart, followed by a fourth dose 6-12 months after the third dose.
A booster dose is recommended at 4-6 years of age.
Administration: Intramuscular injection; not for intravascular, intradermal, or subcutaneous administration.
Adverse Reactions
Common: Injection site reactions (pain, redness, swelling), fever, irritability, drowsiness, loss of appetite.
Less Common: Diarrhea, vomiting, prolonged crying, rash, and mild to moderate fever.
General: Health-care providers should inform the parent/guardian about the benefits and risks of immunization. Vaccination should be postponed in cases of acute or febrile disease.
Hematologic: Caution in individuals with thrombocytopenia or bleeding disorders.
Immune Response: May be suboptimal in immunosuppressed individuals.
Neurologic: Monitoring is required for individuals with a history of convulsions.
Drug Interactions
Concomitant Administration: Can be administered with other vaccines such as Hib, MMR, varicella, pneumococcal conjugate, and hepatitis B at separate sites using different syringes.
Immunosuppressive Treatments: May interfere with the expected immune response.
Storage and Stability
Storage: Store at 2° to 8°C. Do not freeze. Protect from light. Stable for 3 days at temperatures up to 25°C.
Clinical Trials and Efficacy
Immunogenicity: High seroprotection rates for all vaccine antigens. After the primary series, 100% of infants achieved protective antibody levels for diphtheria, tetanus, and poliovirus, with robust pertussis antibody responses.
Safety: Generally well-tolerated with mild to moderate adverse reactions; severe reactions are rare.
