Quadracel Generic Name & Formulations
Store at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.
Mechanism of Action
Protection against diphtheria and tetanus disease is due to the development of neutralizing antibodies to diphtheria toxin and tetanus toxin. There is no well-established serological correlate of protection for pertussis; the effectiveness of Quadracel against pertussis was based on a comparison of pertussis immune responses following Quadracel to those following Daptacel. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis.
Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children 4–6yrs of age: as 5th dose in DTaP series or as 4th or 5th dose in the IPV series following previous DTaP doses of Pentacel, Daptacel, and/or Vaxelis.
Quadracel Dosage and Administration
Severe allergic reaction (eg, anaphylaxis) associated with previous diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine.
Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.
Progressive Neurologic Disorder
Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Do not administer Quadracel to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
Quadracel Boxed Warnings
Management of Acute Allergic Reactions
Have epinephrine hydrochloride solution (1:1000) and other appropriate agents and equipment immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.
Adverse Reactions Following Prior Pertussis Vaccination
Carefully consider the potential benefits and risks of administering Quadracel if any of the following events occur after administration of a pertussis-containing vaccine:
Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.
Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
Persistent, inconsolable crying lasting at least 3 hours within 48 hours.
Seizures with or without fever within 3 days.
If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous vaccine containing tetanus toxoid, the decision to give Quadracel should be based on careful consideration of the potential benefits and possible risks.
Limitations of Vaccine Effectiveness
May not protect all individuals.
May not obtain expected immune response if Quadracel is given to immunocompromised persons, including those receiving immunosuppressive therapy.
Syncope may occur. Procedures should be in place to avoid injury from fainting.
Safety and efficacy of Quadracel has not been established in children less than 4 years of age or children 7 through 16 years of age.
Concomitant Administration with Other Vaccines
In the US clinical trial (Study M5I02), Quadracel was administered concomitantly with 1 or more of the following US-licensed vaccines: MMR vaccines and varicella vaccine.
When Quadracel is given at the same time as another injectable vaccine(s), the vaccines should be administered with different syringes and at different injection sites.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Quadracel.
Quadracel Adverse Reactions
Quadracel Clinical Trials
Immunogenicity - Study M5I02
The immunogenicity of Quadracel was evaluated in children 4 through 6 years of age. Patients received either Quadracel (n=263) or Daptacel + IPOL (n=253) as the 5th dose in the diphtheria, tetanus, and pertussis vaccination series and the 4th or 5th dose in the inactivated poliovirus vaccination series. Patients also received their second dose of MMR and Varicella vaccines, concomitantly.
Antibody levels to diphtheria, tetanus, pertussis (PT, FHA, PRN and FIM) and poliovirus antigens were measured in sera obtained immediately prior to vaccination and 28 days after vaccination. Booster response rates and antibody GMCs/GMTs following Quadracel vaccination were compared to those after DAPTACEL + IPOL vaccination.
Quadracel was non-inferior to Daptacel + IPOL vaccines administered concomitantly at separate sites based on post-vaccination antibody booster response rates and GMCs/GMTs to diphtheria and tetanus.
Quadracel was non-inferior to Daptacel + IPOL based on the post-vaccination booster response rates and GMCs for all pertussis antigens.
Quadracel was non-inferior to Daptacel + IPOL based on the post-vaccination booster response rates and GMTss for all polio types 1, 2, and 3.
Quadracel Patient Counseling
Inform the parent or guardian of the following:
The potential benefits and risks of immunization with Quadracel.
The common adverse reactions that have occurred following administration of Quadracel or other vaccines containing similar components.
Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.