Diphtheria-Tetanus-Acellular Pertussis-Polio- Combined Vaccine Biological Page (DTaP-IPV) Section 7: Biological Product Information Standard #: 07.212 Created by: Province-wide Immunization Program Standards and Quality Approved by: Province-wide Immunization Program Standards and Quality Approval Date: September 10, 2012 Revised: February 15, 2018 Infanrix -IPV Quadracel Manufacturer GlaxoSmithKline Inc. Sanofi Pasteur Ltd. Biological Classification Inactivated Indications for Provincially Funded Vaccine Children 16 months up to and including 4 years of age who are delayed in their immunization schedule when immunization with Haemophilus influenzae type b vaccine (Hib) is not necessary Note: If children younger than 5 years of age are initiating or completing a vaccine series, diphtheria, tetanus, pertussis, polio and Hib combined vaccine would be the vaccine of choice if they have not had a Hib containing vaccine at 15 months of age or older. Children 5 years up to and including 6 years of age initiating (unknown, uncertain or no history of a primary series) or completing a primary immunization series o Child solid organ transplant (SOT) candidates or recipients who also require Hib containing vaccine should receive DTaP-IPV-Hib (see #07.211Diphtheria-Tetanus-Acellular Pertussis-Polio-Haemophilus influenzae type b Conjugate Combined Vaccine Biological Page). It is acceptable to give additional doses of diphtheria, tetanus, pertussis, polio and Hib combined vaccine for children who are delayed in their immunization series. Children who have had pertussis infection should continue to receive pertussis-containing vaccines. Children who are recipients of hematopoietic stem cell transplants (HSCT) should have their immunization schedules restarted post-transplant (see #08.304 Standard for Immunization of Transplant Candidates and Recipients). Children who sustain a tetanus prone wound need to have their tetanus immunization history assessed (Tetanus Prevention, Prophylaxis and Wound/Injury Management Standard #08.400) and should be offered age appropriate vaccine. Individuals travelling to countries currently exporting and/or infected with polio may need special immunization documentation verifying polio immunization. These individuals should consult with a Travel Clinic to determine what documentation is required. Immunization Program Standards Manual Page 1 of 5
Serology Schedule Preferred Use Dose Route Contraindications/ Precautions Pre-Immunization and Post-Immunization There are no serological tests available for pertussis or polio. Serological testing is not typically recommended to assess levels of immunity to diphtheria or tetanus. For additional information see the Alberta Health DAT/TAT Interpretation tables at: https://open.alberta.ca/dataset/715eb289-53b2-4c69-a17e- 60717b9e6eb8/resource/f91417df-26c0-435f-b3da- fea0b031617a/download/aip-adverse-events-following-immunization- DAT-TAT-Levels.pdf Children up to and including 6 years of age: Dose 1 day 0 Dose 2 4 to 8 weeks after dose 1 Dose 3 4 to 8 weeks after dose 2 Dose 4 6 to 12 months after dose 3 Dose 5 given a minimum of 6 months after dose 4 and at a minimum of 4 years of age as dtap-ipv. See Diphtheria Tetanus-Acellular Pertussis- Polio Combined Vaccine Biological Page #07.213. If children younger than 5 years of age are initiating or completing a vaccine series, diphtheria, tetanus, pertussis, polio and Hib combined vaccine may be the vaccine of choice for some of the doses in the series. When the fourth primary immunizing dose is administered after the fourth birthday, the fifth dose (preschool booster dose) is not necessary. There will be no preference indicated for the use of Infanrix -IPV or Quadracel. Both vaccines are safe and immunogenic in eligible children. Children with medical contraindications to one product should be offered the alternate product if supply is available 0.5 ml IM Contraindications: Known severe hypersensitivity to any component of the vaccine Anaphylactic or other allergic reaction to a previous dose of a vaccine containing tetanus, diphtheria, pertussis, or polio. Encephalopathy of unknown etiology (e. g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine. Precautions: Frequent booster doses of tetanus and diphtheria toxoids may lead to severe local and systemic reactions and may be associated with high levels of circulating antitoxin. If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of immunization with a previous dose of vaccine containing tetanus toxoid, it is prudent to withhold subsequent doses of tetanus-containing vaccine. Those who develop GBS outside this interval or have an alternative cause identified may receive subsequent doses of tetanus-containing vaccine. Possible Reactions Common: Tenderness, redness and swelling are the most common reactions and are generally mild and transient in duration. Immunization Program Standards Manual Page 2 of 5
Pregnancy Lactation The most frequent systemic reactions are decreased activity, decreased eating, fussiness, crying, fever, diarrhea and vomiting. The frequency of injection site reactions were higher after the fourth and fifth doses; however, severe tenderness did not increase Rare: Rash Persistent nodules at the site of injection may occur. Large injection site reactions (greater than 50mm) and extensive limb swelling from the injection site beyond one or both joints have been reported. Arthus-type sensitivity may occur. The rate of reactions to acellular pertussis vaccines is less than that reported with whole-cell preparations. As with any immunization, unexpected or unusual side effects can occur. Refer to the product monograph for more detailed information. N/A N/A Composition Diphtheria toxoid - 25 Lf Tetanus toxoid - 10 Lf Acellular pertussis: o Pertussis toxoid (PT) 25 mcg o Filamentous haemagglutinin (FHA) 25 mcg o Pertactin (PRN) 8 mcg Inactivated poliomyelitis vaccine o Type 1 (Mahoney) 40 DU o Type 2 (MEF1) 8 DU o Type 3 (Saukett) 32 DU Blood/Blood Non-medical Ingredients: Sodium chloride Aluminum salts Medium 199 as stabilizer including amino acids, mineral salts and vitamins Water for injection Manufacturing residuals: Trace amounts of: o Neomycin o Polymixin Animal blood (including equine-derived blood) is used as a raw material in the manufacturing process. Does not contain human blood or blood products. Active Ingredients: Diphtheria toxoid - 15 Lf Tetanus toxoid - 5 Lf Acellular pertussis: o Pertussis toxoid (PT) 20 mcg o Filamentous haemagglutinin (FHA) 20 mcg o Pertactin (PRN) 3 mcg o Fimbriae types 2 and 3 (FIM) 5 mcg Inactivated poliomyelitis vaccine o Type 1 (Mahoney) 40 DU o Type 2 (MEF1) 8 DU o Type 3 (Saukett) 32 DU Non-medical Ingredients: Excipients: o Aluminum phosphate (adjuvant) 1.5 mg o 2-phenoxyethanol 0.6% v/v o Polysorbate 80 10 ppm Manufacturing residuals: Trace amounts of: o Bovine serum albumin o Formaldehyde o Glutaraldehyde o Neomycin o Polymyxin B Does not contain human blood or blood products Immunization Program Standards Manual Page 3 of 5
Bovine/Porcine Latex Interchangeability Administration with Other Ingredients of animal origin, including bovine, equine and porcine derived materials, are used as raw materials in the manufacturing process. Does not contain latex. Contains trace amounts of bovine serum. Porcine-derived products are used as raw materials in the early stages of the manufacturing process. Children who begin their immunization with a different combined product may complete immunization using DTaP-IPV. May be given at the same time as other inactivated and live vaccines using a separate needle and syringe for each vaccine. The same limb may be used if necessary, but different sites on the limb must be chosen. Appearance White opalescent suspension During storage white sediment with a clear supernatant may be observed Uniform, cloudy white to off-white suspension. Storage Store at +2 0 C to +8 0 C Do not freeze Do not use beyond the labeled expiry date Store in original packaging when possible to protect from light Vaccine Code DTaP-IPV Antigen Code Tetanus T Diphtheria D Acellular pertussis P Inactivated polio vaccine POL Licensed for Booster dose for children previously immunized with three or four doses of diphtheria, tetanus and acellular pertussis containing vaccines. Recommended for off-license use in Alberta for children less than 7 years of age initiating or completing (less than three doses) an immunization series with diphtheria, tetanus, acellular pertussis and polio. Children 2 months up to and including 6 years of age. Quadracel, containing the acellular pertussis component, became available in the routine Alberta Immunization Program on July 1, 1997. In September 2012, dtap-ipv will replace Quadracel for the routine preschool booster in the childhood immunization program in Alberta. Beginning March 1, 2013 Infanrix -IPV became available for primary immunization in children with delayed immunization schedules. Related Resources: Diphtheria, Tetanus, acellular Pertussis and Polio Vaccine Information Sheet (104503). Immunization Program Standards Manual Page 4 of 5
References: Alberta Health. (2012, November 19). Alberta Immunization Policy. Diphtheria-Tetanus-Acellular Pertussis-Polio Combined Vaccine: INFANRIX -IPV. Alberta Health, Family and Population Health Division. Alberta Health. (2012, November 19). Alberta Immunization Policy. Diphtheria-Tetanus-Acellular Pertussis-Polio Combined Vaccine: QUADRACEL. Alberta Health, Family and Population Health Division. Alberta Health. (2014, January). Alberta Immunization Policy. Adverse Event Following Immunization (AEFI) Policy for Alberta Health Services Public Health. Alberta Health. Alberta Health. (2007, November). Public Health and Compliance Division Alberta Immunization Policy Adverse Events. Following Immunization Interpretation of DAT and TAT Levels Centers for Disease Control and Prevention. (2011). General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices. Morbidity and Mortality Weekly Report, 60 (2), 36-39. GlaxoSmithKline. (2011, August 16). Product Monograph. Infanrix-IPV: Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliomyelitis Vaccine. National Advisory Committee on Immunization. (2012). Canadian Immunization Guide (Evergreen Edition). Ottawa, ON: Public Health Agency of Canada. Sanofi Pasteur Limited. (2011, August 4). Product Monograph. Quadracel: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Combined with Inactivated Poliomyelitis Vaccine. Immunization Program Standards Manual Page 5 of 5