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Diphtheria, tetanus, pertussis (5 component), hepatitis b, poliomyelitis and


Vaccine containing diphtheria, tetanus, pertussis (5 component), hepatitis b, poliomyelitis and haemophilus influenzae b.

Drugs List

  • diphtheria & tetanus with pertussis (5 component) hepatitis b poliomyelitis & h. influenzae type b injection
  • VAXELIS vaccine suspension for injection
  • Therapeutic Indications


    Diphtheria - prophylaxis
    Immunisation against haemophilus influenzae type B invasive disease
    Pertussis - prophylaxis
    Poliomyelitis - prophylaxis
    Prophylaxis of hepatitis B
    Tetanus - prophylaxis



    Children aged 6 weeks and above
    Primary vaccination
    Two or three doses, with an interval of at least 1 month between doses.

    Booster vaccination
    A booster dose should be administered at least 6 months after the last priming dose.

    Booster dose should be given in accordance with the official recommendations. As a minimum, a dose of Hib vaccine must be administered.

    Additional Dosage Information

    Where a hepatitis B vaccine is given at birth, this vaccine can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used. This vaccine can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.


    For intramuscular injection only.


    Children under 6 weeks
    Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
    History of anaphylaxis
    Severe febrile conditions
    Uncontrolled epileptic disorder
    Uncontrolled neurological disorder

    Precautions and Warnings

    History of febrile convulsions
    History of post vaccination pyrexia above 40 degrees C within 48 hours
    Premature infants
    Previous post vaccination convulsions within 3 days
    Previous post vaccination crying for over 3 hours within 48 hours
    Previous post vaccination shock like state within 48 hours
    Guillain Barre syndrome within 6 weeks of previous tetanus toxoid vaccine
    Immunodeficiency syndromes

    No protection against other strains of haemophilus influenzae or meningitis
    Postpone immunisation if there is active or suspected infection
    Impaired response possible in immunocompromised patients
    Pre-treatment medical history and clinical examination
    Vaccine may not be effective in 100% of patients
    May contain trace amounts of formaldehyde
    May contain trace amounts of glutaral
    May contain trace amounts of neomycin
    May contain trace amounts of polymyxin
    May contain trace amounts of streptomycin
    Do not mix with other vaccines in the same syringe
    Inject other vaccines at different sites
    Record name and batch number of administered product
    Resuscitation facilities must be immediately available
    Monitor patient for 2-3 days if history of febrile convulsions
    Risk of apnoea in premature infants - monitor respiration for 72 hours
    May affect results of some laboratory tests
    Follow national immunisation guidelines

    This vaccine should not be administered if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, polio and H. influenza type B vaccines.

    Note that the rate of fever is higher when this vaccine is co-administered with a pneumococcal conjugate vaccine (PCV13) following the booster dose in the second year of life, compared to the primary series. These reactions were mild or moderate (less than 39.5°C) and transient.

    Pregnancy and Lactation


    Not indicated in patients of child bearing age, relevant data is not available.


    Not indicated in patients of child bearing age, relevant data is not available.

    Side Effects

    Abdominal pain
    Anaphylactic reaction
    Bruising at injection site
    Decreased appetite
    Erythema multiforme
    Facial oedema
    Febrile convulsions
    Hypersensitivity reactions
    Hypotonic hyporesponsive episode
    Increased appetite
    Induration (injection site)
    Injection site reactions
    Limb swelling
    Nodules (injection site)
    Sensation of warmth
    Sleep disorders
    Swelling (injection site)

    Effects on Laboratory Tests

    False positive urine tests can be observed for at least 30 days following vaccination due to Hib capsular polysaccharide antigen being excreted in urine. Other tests should be performed in order to confirm Hib infection during this period.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2021

    Reference Sources

    Summary of Product Characteristics: Vaxelis suspension for injection in pre-filled syringe. Sanofi Pasteur. Revised January 2021.

    Immunisation against infectious disease - The Green Book.
    Available at:
    Last accessed: 17 June 2021

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