Diphtheria-Tetanus-Acellular Pertussis Combined Vaccine Biological Page (dtap)

Transcription

1 Diphtheria-Tetanus-Acellular Pertussis Cmbined Vaccine Bilgical Page (dtap) Sectin 7: Bilgical Prduct Infrmatin Standard #: Created by: Apprved by: Prvince-wide Immunizatin Prgram Standards and Quality Prvince-wide Immunizatin Prgram Standards and Quality Apprval Date: February 8, 2012 Revised: September 5, 2018 Adacel Manufacturer Sanfi Pasteur Limited GlaxSmithKline Inc. Bilgical Classificatin Indicatins fr Prvincially Funded Vaccine Inactivated Children 7 years up t and including 17 years f age: with an uncertain r n histry f a primary series r thse wh have nt cmpleted a primary series fr diphtheria, tetanus and pertussis Nte: If pli vaccine is als indicated cmbined dtap-ipv vaccine shuld be used. See Diphtheria-Tetanus-Acellular Pertussis-Pli Cnjugate Cmbined Vaccine Bilgical Page # wh are due fr a reinfrcing dse f diphtheria, tetanus and pertussis vaccine in grade 9 and have nt received a dse f acellular pertussis vaccine as an adlescent (i.e.,12 years up t and including 17 years f age) as part f the rutine schl immunizatin prgram wh are candidates r recipients f SOT - immunize using the rutine age apprpriate schedule fr tetanus-diphtheria-pertussis cntaining vaccine fr recipients f HSCT refer t Transplant Guidelines # t determine apprpriate tetanus-diphtheria-pertussis cntaining vaccine wh sustain a tetanus prne wund need t have their tetanus immunizatin histry assessed ( Tetanus Preventin, Prphylaxis and Wund/Injury Management Standard #08.400) Nte: Fr questins related t Travel and r Fr Sale vaccine refer t AHS Travel Health and Cntracted Immunizatin Services resurces. Ntes: Students in ungraded classes r thse wh d nt cntinue in the schl system t grade 9 can still be immunized n a case by case basis, generally at 14 years up t and including 18 years f age. The guiding principle shuld be t ffer prtectin t students prir t them leaving the schl system. Grade 9 students wh have received a dse f tetanus, diphtheria, acellular pertussis cntaining vaccine prir t 12 years f age shuld receive a dse f dtap in grade 9 regardless f the interval in rder t ensure best prtectin as an adlescent and adult. Grade 9 students wh have received a dse f Td (i.e., as part f wund management) shuld receive a dse f dtap vaccine regardless f the spacing. dtap vaccine may be prvided t acute care emergency departments and urgent care centers but will nt rutinely be prvided t physician ffices at this time. Children needing tetanus prphylaxis fr wund management shuld be referred t public health fr age-apprpriate tetanus cntaining vaccine. If this is nt pssible they shuld be prvided with available tetanus cntaining vaccine fr wund management and subsequently referred t Immunizatin Prgram Standards Manual Page 1 f 7

2 public health fr further assessment f immunizatin recmmendatins. See Tetanus Preventin, Prphylaxis and Wund/Injury Management Standard # ). Individuals 18 years f age and lder: Wh are initiating r cmpleting a primary series f tetanus-diphtheria cntaining vaccine shuld have ne dse in the Td series given as dtap vaccine. Wh have nt received an adult dse f dtap vaccine as they present fr service including pregnant wmen 26 weeks f gestatin r greater. effrts shuld be made t ffer an adult dse f dtap vaccine t health care wrkers with a pririty fr thse wh prvide care t children yunger than 12 mnths f age. In an utbreak situatin based n lcal r reginal epidemilgy the MOH may authrize: dtap fr pregnant wmen wh are 26 weeks gestatin r greater regardless f immunizatin histry with tetanus-diphtheria-pertussis cntaining vaccine and regardless f the interval frm the last tetanus/diphtheria r pertussis cntaining vaccine. priritizatin f dtap fr adults wh have cntact r anticipate cntact with infants and have nt received a dse f dtap as an adult (18 years f age and lder). Cnsideratin shuld be given t ffering dtap when pregnant wmen wh are 26 weeks gestatin r greater, irrespective f their immunizatin histry, travel t areas where pertussis is circulating. Fr candidates r recipients f SOT immunize using the rutine age apprpriate schedule fr tetanus-diphtheria-pertussis cntaining vaccine. Fr recipients f HSCT refer t Transplant Guidelines # t determine apprpriate tetanus-diphtheria-pertussis cntaining vaccine. Fr candidates r recipients f SOT immunize using the rutine age apprpriate schedule fr tetanus-diphtheria-pertussis cntaining vaccine. Wh sustain a tetanus prne wund need t have their tetanus immunizatin histry assessed (see Tetanus Preventin, Prphylaxis and Wund/Injury Management Standard #08.400). Clse cntacts (e.g. husehld, classrm) f a diphtheria case shuld receive a dse f a diphtheria txid-cntaining vaccine as apprpriate fr age unless the cntact is knwn t have been fully immunized fr age and the last dse f diphtheria txid-cntaining vaccine was given within 10 years. The diphtheria txid-cntaining vaccine series shuld be cmpleted fr previusly unimmunized r incmpletely immunized cntacts. Fr disease investigatin, cntact assessment and reprting requirements, refer t Public Health Ntifiable Disease Guidelines Diphtheria. Carriers f diphtheria, if nt previusly immunized, and thse f unknwn immunizatin status shuld receive immunizatin prmptly and ensure cmpletin f vaccine series. If a carrier has been immunized previusly but has nt received a bster f diphtheria txid within 10 years, a bster dse f a diphtheria txid-cntaining vaccine shuld be given. Infectin with diphtheria des nt necessarily cnfer immunity; therefre immunizatin shuld be given during cnvalescence frm diphtheria disease. Serlgy Pre-Immunizatin and Pst immunizatin There is n serlgical test available fr pertussis. Immunizatin Prgram Standards Manual Page 2 f 7

3 Serlgical testing is nt typically recmmended t assess levels f immunity t diphtheria r tetanus. Fr additinal infrmatin see the Alberta Health DAT/TAT Interpretatin tables. Schedule Preferred Use Dse Preparatin/ Recnstitutin Rute Cntraindicatins/ Precautins Primary Series fr eligible individuals: 7 years up t and including 17 years f age: Dse 1 day 0 Dse 2 4 t 8 weeks after dse 1 Dse 3 6 t 12 mnths after dse 2 18 years f age and lder: A single dse f dtap shuld be given t adults as part f a primary series f tetanus/diphtheria cntaining vaccine. Any remaining dses in the primary series shuld be given using Td vaccine ensuring the apprpriate spacing. Reinfrcing Dse: A single reinfrcing dse f dtap shuld be given t eligible children 12 years up t and including 17 years f age as utlined in the indicatins sectin (typically given in the grade 9 schl immunizatin prgram). A single reinfrcing dse f dtap shuld be given t adults 18 years f age and lder presenting fr a Td bster, if they have nt received a dse f dtap as an adult. Spacing Cnsideratins: In rder t prvide prtectin fr pertussis eligible individuals may receive a dse f dtap vaccine regardless f the spacing since the last dse f Td. Fr individuals being fllwed fr wund management see Tetanus Preventin, Prphylaxis and Wund/Injury Management Standard #08.400). Individuals wh have had tetanus, diphtheria r pertussis illness shuld still be immunized as these clinical infectins d nt always cnfer immunity. In Alberta, dtap is nt prvided t individuals less than 7 years f age. Individuals less than 7 years f age shuld receive the age apprpriate cmbined vaccines as per prvincial eligibility criteria. There will be n preference indicated fr the use f Adacel r in specific age r risk grups. Bth vaccines are safe and immungenic in individuals fur years f age and lder. Persns with medical cntraindicatins t ne prduct shuld be ffered the alternate prduct if supply is available. 0.5 ml See vaccine prduct mngraph IM Cntraindicatins: Knwn severe hypersensitivity t any cmpnent f the vaccine. Anaphylactic r ther allergic reactin t a previus dse f vaccine cntaining tetanus, diphtheria r pertussis antibdies. Immunizatin Prgram Standards Manual Page 3 f 7

4 Encephalpathy f unknwn etilgy (e.g., cma, decreased level f cnsciusness, prlnged seizures) within 7 days f a previus dse f a pertussis-cntaining vaccine. shuld nt be administered t individuals wh have experienced transient thrmbcytpenia fllwing a previus dse f diphtheria/tetanus cntaining vaccine. Cnsult with MOH n a case-by-case basis t determine immunizatin recmmendatins. Precautins: If Guillain-Barré Syndrme (GBS) ccurred within 6 weeks f immunizatin with a previus dse f vaccine cntaining tetanus txid, it is prudent t withhld subsequent dses f tetanus-cntaining vaccine. Thse wh develp GBS utside this interval r have an alternative cause identified may receive subsequent dses f tetanus-cntaining vaccine. Frequent bster dses f tetanus and diphtheria txids may lead t severe lcal and systemic reactins and may be assciated with high levels f circulating antitxin. Nte: In rder t prvide prtectin fr pertussis Alberta Health recmmends prviding dtap regardless f spacing since last dse f Td. There is n mnvalent acellular pertussis vaccine available in Canada at this time. Pssible Reactins Cmmn: Pain, redness and swelling at the injectin site, usually mild and transient in duratin. Headache, fever, tiredness, generalized bdy ache, sre/swllen jints, chills, nausea, vmiting, diarrhea, anrexia, rash, axillary lymph nde swelling and myalgia. Rare: Severe lcal reactins ccur rarely and may be assciated with high levels f circulating tetanus antitxin. Rarely, increased sweating, pruritus, allergic reactins and anaphylaxis were reprted. The fllwing additinal adverse events have been reprted frm pstmarketing surveillance: urticaria, pruritus, anaphylaxis, neurlgical cmplicatins, musculskeletal and cnnective tissue disrders. Anaphylaxis. As with any immunizatin, unexpected r unusual side effects can ccur. Refer t the prduct mngraph fr mre detailed infrmatin. Pregnancy Lactatin dtap may be ffered t pregnant wmen 26 weeks gestatin r greater if indicated (See Indicatins Sectin). During utbreak situatins, the zne MOH may authrize use f dtap vaccine with each pregnancy fr pregnant wmen 26 weeks gestatin r greater. Immunizatin during pregnancy requires careful cnsideratin f the risks frm the disease versus the benefit f vaccine. Adequate human data n the use f dtap during pregnancy is nt currently available hwever; inactivated vaccines and txids are usually cnsidered safe fr the fetus. Can be administered t eligible breastfeeding wmen. Cmpsitin Each 0.5 ml dse cntains: Each 0.5 ml dse cntains: Immunizatin Prgram Standards Manual Page 4 f 7

5 Bld/Bld Prducts Bvine/Prcine Prducts Latex Adacel Active Ingredients: tetanus txid - 5 Lf diphtheria txid - 2 Lf five purified acellular pertussis antigens: pertussis txid (PT) µg filamentus haemagglutinin (FHA) 5 µg pertactin (PRN) 3 µg fimbriae types 2 and 3 (FIM) - 5 µg Nn-medical Ingredients: aluminum phsphate (adjuvant) 1.5 mg 2-phenxyethanl 0.6% v/v Trace amunts f: frmaldehyde glutaraldehyde Des nt cntain human bld/bld prducts. Bvine-derived materials are cmpnents in the prductin prcess. Bvine cells are remved during purificatin f the vaccine. Prcine prducts are used in the early manufacturing prcess. Des nt cntain latex. Active Ingredients: tetanus txid - 5 Lf diphtheria txid - 2 Lf three purified acellular pertussis antigens: pertussis txid (PT) - 8 µg filamentus haemagglutinin (FHA) 8 µg pertactin (PRN) 2.5 µg Nn-medical Ingredients: aluminum (as aluminum salts) sdium chlride water fr injectin Residues: disdium phsphate frmaldehyde glutaraldehyde glycine mnptassium phsphate plysrbate 80 ptassium chlride Animal bld (including equine-derived bld) is used as a raw material in the manufacturing prcess. Des nt cntain human bld r bld prducts. Ingredients f animal rigin including bvine, equine and prcine derived materials are used as raw materials in the manufacturing prcess. Interchangeability Administratin with Other Prducts dtap vaccines may be used interchangeably prvided the apprpriate dse and schedule recmmended by the manufacturer are used. May be given at the same time as ther inactivated and live vaccines using a separate needle and syringe fr each vaccine. The same limb may be used if necessary, but different sites n the limb must be chsen. If dtap and TIG are given at the same time fr wund management, use separate anatmic sites (different limbs) fr each injectin. Appearance Shake vial well t prduce a unifrm, cludy suspensin. Shake well in rder t btain a hmgeneus turbid white suspensin. Immunizatin Prgram Standards Manual Page 5 f 7

6 Strage Stre at +2 0 C t +8 0 C. D nt freeze. D nt use beynd the labeled expiry date. Stre in riginal packaging when pssible t prtect frm light. Vaccine Cde Antigen Cde Licensed fr dtap Tetanus T Diphtheria D Acellular pertussis - P Licensed fr bster immunizatin fr individuals 4 years f age and lder. In Alberta, dtap vaccine has been apprved fr ff license use fr a primary series fr individuals 7 years up t and including 17 years f age. Ntes: dtap vaccine was implemented as the reinfrcing dse fr students in Grade 9 as f September 1, dtap vaccine was implemented fr the fllwing adult ppulatins n February 1, 2012: healthcare wrkers prviding care t children under 12 mnths f age adults wh have nt received an adlescent r adult dse f dtap vaccine as they present fr service. In July 2014 an adult dse f dtap was implemented regardless f previus histry f adlescent dtap vaccine. Related Resurces: Diphtheria, Tetanus, Acellular Pertussis Vaccine Infrmatin Sheet (104516). Immunizatin Prgram Standards Manual Page 6 f 7

7 References: Adacel 1. Alberta Health, (2017, September 20). Alberta Health, Public Health and Cmpliance Divisin Alberta Immunizatin Plicy - Bilgical Prducts - dtap 2. Alberta Health. (2014, January). Alberta Immunizatin Plicy. Adverse Event Fllwing Immunizatin (AEFI) Plicy fr Alberta Health Services Public Health. Alberta Health. 3. Alberta Health. (2007, Nvember). Public Health and Cmpliance Divisin Alberta Immunizatin Plicy Adverse Events. Fllwing Immunizatin Interpretatin f DAT and TAT Levels 4. Centers fr Disease Cntrl and Preventin. (2011). General Recmmendatins n Immunizatin: Recmmendatins f the Advisry Cmmittee n Immunizatin Practices. Mrbidity and Mrtality Weekly Reprt, 60 (2), Centers fr Disease Cntrl and Preventin. Preventing Tetanus, Diphtheria and Pertussis Amng Adults: Use f Tetanus Txid, Reduced Diphtheria Txid and Acellular Pertussis Vaccine: Recmmendatins f the Advisry Cmmittee n Immunizatin Practices. Mrbidity and Mrtality Weekly Reprt, 55 (17). 6. Centers fr Disease Cntrl and Preventin. Updated Recmmendatins fr Use f Tetanus Txid, Reduced Diphtheria Txid and Acellular Pretussis Vaccine (Tdap) in Pregnant Wmen and Persns Wh Have r Anticipate Having Clse Cntact with an Infant Aged < 12 Mnths: Recmmendatins f the Advisry. Mrbidity and Mrtality Weekly Reprt, 60 (41). 7. GlaxSmithKline. (2018, March 5). Prduct Mngraph. Bstrix: Cmbined Diphtheria, Tetanus, Acellular Pertussis (Adsrbed) Vaccine fr Bster Vaccinatin. 8. Grabenstein, J. D. (2013). ImmunFacts: Vaccines and Immunlgic Drugs (38th Revisin ed.). St. Luis, MO: Wlters Kluwer Health. 9. Natinal Advisry Cmmittee n Immunizatin. (2012). Canadian Immunizatin Guide (Evergreen Editin). Ottawa, ON: Public Health Agency f Canada. 10. Natinal Advisry Cmmittee n Immunizatin. (2005). Interval Between Administratin f Vaccines Against Diphtheria, Tetanus and Pertussis. Canada Cmmunicable Disease Reprt, 31 (ACS-9). 11. Natinal Advisry Cmmittee n Immunizatin. (2003). Preventin f Pertussis in Adlscents and Adults. Canada Cmmunicable Disease Reprt, 29 (ACS-5). 12. Natinal Advisry Cmmittee n Immunizatin. (2000). Statement n Adult/Adlscent Frmulatin f Cmbined Acellular Pertussis, Tetanus and Diphtheria Vaccine. Canada Cmmunicable Disease Reprt, 26 (ACS-1). 13. Sanfi Pasteur Limited. (2012, June 11). Prduct Mngraph. Adacel: Tetanus Txid, Reduced Diphtheria Txid and Acellular Pertussis Vaccine Adsrbed. Immunizatin Prgram Standards Manual Page 7 f 7