QUADRACEL

Generic Name & Formulations:

Diphtheria and tetanus toxoids, acellular pertussis; aluminum phosphate adsorbed + inactivated poliovirus vaccine; susp for IM inj; contains 2-phenoxyethanol, and residual amounts of formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, polymyxin B; preservative-free.

Company:

Vaccines

Vaccines:

Indications for: QUADRACEL

Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children 4–6yrs of age: as 5^th dose in DTaP series or as 4^th or 5^th dose in the IPV series following previous DTaP doses of Pentacel, Daptacel, and/or Vaxelis.

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.

Adult Dosage:

Not recommended.

Children Dosage:

<4yrs or >6yrs: not established. 4–6yrs: Each dose is 0.5mL IM, given once into deltoid muscle.

QUADRACEL Contraindications:

Anaphylaxis associated with any previous dose or component. Encephalopathy within 7 days of a previous pertussis-containing vaccine. Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, or progressive encephalopathy).

QUADRACEL Warnings/Precautions:

Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), seizures (within 3 days), Guillain-Barre Syndrome (within 6 weeks) of previous tetanus toxoid-containing vaccine. Immunocompromised. Have epinephrine inj (1:1000) available. Pregnancy (Cat.C).

QUADRACEL Classification:

DTaP + IPV.

QUADRACEL Interactions:

Concomitant vaccines: see full labeling. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

Adverse Reactions:

Inj site reactions (eg, pain, increase in arm circumference, erythema, swelling), mylagia, malaise, headache, fever.

Generic Drug Availability:

How Supplied:

Single-dose vials (0.5mL)—10

QUADRACEL Rx