Diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type B vaccine

Powder and susp for susp for inj: Shake the vial or pre-filled syringe containing diphtheria, tetanus, pertussis and inactivated poliomyelitis component until a homogenous susp is obtained. Add the entire contents of the vial or pre-filled syringe to the other vial containing the lyophilised HIB powder component. Shake the other vial well until the powder is completely dissolved, resulting in a slightly cloudy and uniform susp. Recommendations for reconstitution of the vaccine may vary among individual products or countries (refer to specific product guidelines).

Hypersensitivity. History of encephalopathy (e.g. reduced level of consciousness, prolonged seizures, coma) of unknown cause occurring within 7 days after previous administration of a pertussis-containing vaccine; progressive neurologic disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy (until a treatment plan is determined and the condition is stabilised).

Patient with history of fever ≥40°C of unknown cause, collapse or shock-like state (hypotonic-hyporesponsive episode), and persistent or inconsolable crying (lasting ≥3 hours) which occurred within 48 hours after administration of a pertussis-containing vaccine; history of convulsions (with or without fever) which occurred within 3 days after administration of a pertussis-containing vaccine; bleeding disorders, including thrombocytopenia and haemophilia; Guillain-Barre syndrome which occurred within 6 weeks of receiving a prior tetanus toxoid-containing vaccine. Patients receiving anticoagulant therapy. Delay vaccination in patients with moderate or severe acute illness (with or without fever) and during periods of severe immunosuppression (e.g. patients receiving chemotherapy, radiation therapy, or other immunosuppressive treatment [including high-dose corticosteroids]) if appropriate. The HIB component does not protect against diseases caused by other types of Haemophilus influenzae nor against meningitis caused by other organisms. Infants (especially those born prematurely) and children.

Significant: Syncope, anaphylactoid or hypersensitivity reactions; bleeding or haematoma (particularly in patients with bleeding disorders); apnoea following IM vaccination in very premature infants (born ≤28 weeks of gestation).
Blood and lymphatic system disorders: Lymphadenopathy.
Gastrointestinal disorders: Vomiting, diarrhoea.
General disorders and administration site conditions: Fever (≥38°C), lethargy, inj site reactions (e.g. pain, erythema, swelling, induration).
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Somnolence.
Psychiatric disorders: Irritability, restlessness, abnormal crying.

IM: C

Consider respiratory monitoring for 48-72 hours when given to very premature infants (≤28 weeks of gestation) or those with a history of respiratory immaturity. Monitor for signs of syncope and hypersensitivity reactions for 15 minutes after vaccination.

May result in reduced immune response when used concomitantly with immunosuppressive treatments (e.g. antimetabolites, alkylating agents, cytotoxic agents, high-dose corticosteroids).

May cause false-positive antigen detection test results for suspected HIB infection within 1-2 weeks of vaccination.

Description:
Mechanism of Action: Diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type B vaccine is a non-live combination vaccine containing diphtheria toxoid, tetanus toxoid, acellular pertussis antigens, inactivated poliovirus vaccine with 3 serotypes (types 1, 2, and 3), and Haemophilus influenzae type B conjugate vaccine. It promotes immunity against the bacteria that cause diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type B.

Store between 2-8°C. Do not freeze. Protect from light.

Vaccines, Antisera & Immunologicals

J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.

Buckingham R (ed). Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Haemophilus Influenzae Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2024.

Diphtheria and Tetanus Toxoids, Acellular Pertussis, Poliovirus and Haemophilus B Conjugate Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/04/2024.

Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae Type B Conjugate Vaccine; Inactivated Poliovirus Vaccine, IPV. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/04/2024.

GlaxoSmithKline NZ Ltd. Infanrix-IPV + Hib Suspension for Injection data sheet 30 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 04/04/2024.

Infanrix-IPV + Hib Powder and Suspension for Suspension for Injection (SmithKline Beecham Limited Trading as GlaxoSmithKline UK). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Infanrix-IPV + Hib Vaccine (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/04/2024.

Joint Formulary Committee. Diphtheria with Tetanus, Pertussis, Poliomyelitis and Haemophilus influenzae Type B Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2024.

Pentacel Vaccine (Sanofi Pasteur Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.