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As with other vaccines, administration of Boostrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give doses of pertussis-containing vaccines should be carefully considered: temperature of ≥40.0°C within 48 hours of vaccination, not due to another identifiable cause;
collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;
persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of vaccination;
convulsions with or without fever, occurring within 3 days of vaccination.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunization until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
As with all injectable vaccines appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Boostrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. If in accordance with official recommendations, the vaccine may need to be administered subcutaneously to these subjects. With both routes of administration, firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
A history or a family history of convulsions and a family history of an adverse event following DTP vaccination do not constitute contraindications.
Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication for diphtheria, tetanus and pertussis vaccination. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Extremely rare cases of collapse or shock-like state (hypotonic-hyporesponsiveness episode) and convulsions within 2 to 3 days of vaccination have been reported in DTPa and DTPa combination vaccines.
Boostrix should under no circumstances be administered intravenously.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Effects on Ability to Drive and Use Machines: The vaccine is unlikely to produce an effect on the ability to drive and use machines.
