Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP
Pentacel® (Act-HIB® [Haemophilus b conjugate vaccine (tetanus protein conjugate)] reconstituted with Quadracel®, [DTaP-IPV-Hib]), Sanofi Pasteur Ltd.
Quadracel – the usual immunization schedule is 1 dose (0.5 mL) given at 2, 4, 6, and 18 months of age. *same dosage no matter the weight of child*
Each dose (0.5 mL) of sterile, uniform, cloudy, white-to-off-white suspension contains 20 µg of pertussis toxoid (PT), 20 µg of filamentous haemagglutinin (FHA), 5 µg fimbriae types 2 and 3 (FIM), 3 µg pertactin (PRN), 15 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 40 D-antigen units of poliovirus type 1 (Mahoney), 8 D-antigen units of poliovirus type 2 (MEF1), and 32 D-antigen units of poliovirus type 3 (Saukett). Nonmedicinal ingredients: aluminum phosphate(aluminum 0.33 mg)1.5 mg, 2-phenoxyethanol0.6% v/v, polysorbate 8010 ppm (by calculation); trace amounts of bovine serum albumin, formaldehyde, glutaraldehyde, neomycin, and polymxin B. Human diploid cells
Children who have a severe allergy to antibiotics called neomycin or polymyxin B, formaldehyde, aluminum; should not receive Quadracel. Children who have had a severe allergy or neurological reaction to a previous dose of Quadracel (or a vaccine containing similar components) should also not receive the vaccine. Signs of severe allergy include hives, swelling of the mouth and throat, wheezing, chest tightness, difficulty breathing, difficulty swallowing, hypotension and shock. Children who have a neurological disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy) that is untreated or unstable, should not receive this vaccine.Children who have had encephalopathy (brain inflammation) within 7 days of a previous dose of a pertussis-containing vaccine, should not receive this vaccine
The potential risk of apnea and the need for respiratory monitoring for 48 – 72 hours should be
considered when administering the primary immunization series to very premature infants
Warnings/precautions before taking Quadracel should be identified and discussed before considering this vaccine, they include; If your child has a bleeding disorder or is taking anticoagulants (blood thinners), anyone with a weakened immune system; people with AIDS or cancer, people taking antirejection medications after an organ transplant, people receiving chemotherapy, or people taking any medication that suppresses the immune system. If your child has an increased risk of seizures,
This medication is not recommended for children under 2 months of age or for children 7 years of age and older.
Call your health care provider if your child has any of the following within 14 days of getting the needle: hives, swelling of the face or mouth, trouble breathing: high fever (over 40°C), crying for more than three hours, convulsions or seizures, a paler skin colour and drowsiness, or any other severe or unexpected symptoms. Seek medical attention if limpness, vomiting or unresponsiveness occur.
Side effects: fever, fussiness, crying, decreased activity, loss of appetite, redness, swelling and tenderness at the injection site, a lump under the skin where the needle was given, which may last a week or sometimes months, some nausea and vomiting, especially when fever is present. Somnolence, convulsion, febrile convulsion, HHE, hypotonia, Cyanosis, Pallor, brachial neuritis, GBS,
Pentacel information not available. Vaccine with Quadracel has been replaced with the combined Pediacel
Still a 0.5ml dose given to any size child
Diphtheria toxoid, tetanus toxoid, acellular pertussis [pertussis toxoid (PT), filamentous
haemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM)], inactivated poliomyelitis
vaccine [type 1 (Mahoney), type 2 (MEF1), type 3 (Saukett)] and purified polyribosylribitol
phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b covalently bound to
Clinically Relevant Nonmedicinal Ingredients
Excipients: aluminum phosphate (adjuvant), 2-phenoxyethanol, polysorbate 80.
Manufacturing process residuals: bovine serum albumin, neomycin, polymyxin B and trace
amounts of streptomycin, formaldehyde and glutaraldehyde
Hypersensitivity, Acute Neurological Disorders,Febrile or Acute Disease,
bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant
therapy, allergic reactions, immunocompromised persons, Encephalopathy (e.g., 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, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Pertussis vaccine should not be administered to persons with such conditions until a treatment regimen has been established and the condition has stabilized.
NACI states that the rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number of prior doses and level of pre-existing antitoxins. -The more tetanus containing vaccines you get, the increased risk of reaction. Possibly due to accumulation of ingredients.
GBS, demyelinating diseases of the central nervous system, peripheral mononeuropathies, and cranial mononeuropathies. Hypersensitivity, anaphylactic reaction (such as urticaria, angioedema). Irritability, screaming,
Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic hyporesponsive episode (infant appears pale, hypotonic [limp] and unresponsive to parents). Pallor, Apnea, Erythema, rash, Pain in vaccinated limb. High fever (>40.5°C), injection site mass, asthenia, and listlessness. Large injection site reactions (>50 mm) including extensive limb swelling which may extend from the injection site beyond one or both joints. Edematous reactions affecting one or both lower limbs
Granuloma or sterile abscess at the injection site has been reported with a product containing the
Act-HIB® (Haemophilus b conjugate vaccine [tetanus protein conjugate]), Sanofi Pasteur Ltd.
Liquid PedvaxHIB® (Haemophilus b conjugate vaccine [meningococcal protein conjugate]), Merck Frosst Canada Ltd.
Diphtheria Toxoid was first introduced in 1926
Tetanus Toxoid was first introduced in 1940