BOOSTRIX-IPV

What it is

BOOSTRIX-IPV is a pertussis vaccine–acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus type 1, 2 and 3 (Vero cell) . BOOSTRIX-IPV is a diphtheria-tetanus-acellular pertussis combination vaccine (dTpa) combined with inactivated poliovirus vaccine with a reduced content of pertussis toxoid, filamentous haemagglutinin and diphtheria toxoid compared to paediatric diphtheria-tetanus-acellular pertussis (DTPa) formulations . BOOSTRIX-IPV is supplied in a prefilled syringe for single dose (0.5 mL) use .

Approved indications —

Active immunisation against diphtheria in adults, adolescents and children aged 4 years and older as a booster following primary immunisation — Active immunisation against tetanus in adults, adolescents and children aged 4 years and older as a booster following primary immunisation — Active immunisation against pertussis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation — Active immunisation against poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation BOOSTRIX-IPV may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus .

Dosing overview

BOOSTRIX-IPV should be administered as a single injection of one dose (0.5 mL) by the intramuscular route, with the same dose applying to all age groups . The preferred site is into the deltoid muscle . BOOSTRIX-IPV can be used for repeat vaccination after a previous dose of BOOSTRIX-IPV or Adacel, to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals .

Key safety warnings

Anaphylaxis has been reported after receipt of some preparations containing diphtheria toxoid, tetanus toxoid, and/or pertussis antigens . Appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine, and adrenaline (epinephrine) injection (1:1000) must be immediately available in case of unexpected anaphylactic or serious allergic reactions . If Guillain-Barré Syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including BOOSTRIX-IPV, should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary immunisation schedule has been completed . BOOSTRIX-IPV should not be administered to individuals with progressive or unstable neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established, the condition has stabilised and the benefit clearly outweighs the risk . Syncope (fainting) can occur following, or even before, administration of injectable vaccines including BOOSTRIX-IPV, and procedures should be in place to prevent falling injury and manage syncopal reactions .

Contraindications

BOOSTRIX-IPV should not be administered to individuals with a history of severe allergic reaction after previous administration of the vaccine or a vaccine containing the same components or constituents . BOOSTRIX-IPV should not be administered to individuals who experienced an encephalopathy of unknown origin within 7 days of previous immunisation with a pertussis-containing vaccine, or to individuals who have experienced other neurological complications following previous immunisation with any of the antigens in BOOSTRIX-IPV . Generally vaccination must be postponed in cases of moderate or severe febrile and/or acute disease, though low-grade fever does not constitute a contraindication .

PBS listing

The document provided does not contain information about PBS listing details for BOOSTRIX-IPV, including strength, item count, restriction type, or ex-manufacturer price.

Regulatory history

BOOSTRIX-IPV 0.5 mL injection syringe was first listed on the ARTG on 2004-07-08 . In July 2016, the PBAC recommended a change to the circumstances under which combined diphtheria, tetanus and acellular pertussis (dTpa) vaccine is made available as a designated vaccine for the National Immunisation Program (NIP) to include vaccination of women during each pregnancy to reduce pertussis disease in infants and in mothers, on the basis of cost-effectiveness compared with no vaccination .