BOOSTRIX Suspension for injection in pre-filled syringe Ref.[50806] Active ingredients: Diphtheria toxoid Pertactin Pertussis filamentous hemagglutinin Pertussis toxoid Tetanus toxoid

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).

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.

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

As for any vaccination, the risk-benefit of immunising with Boostrix-IPV or deferring this vaccination should be weighed carefully in a child suffering from a new onset or progression of a severe neurological disorder.

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-IPV should be administered with caution to subjects with thrombocytopenia (see section 4.3) or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. If in accordance with official recommendations, the vaccine may 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.

Boostrix-IPV should in no circumstances be administered intravascularly.

A history of febrile convulsions, 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. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. 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.

Excipients with known effect

Boostrix-IPV contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

This medicine contains 0.0298 micrograms phenylalanine in each dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium- free’.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Use with other vaccines or immunoglobulins

Boostrix-IPV may be administered concomitantly with any of the following monovalent or combination vaccines: measles, mumps, rubella, varicella (MMR/V) and human papilloma virus (HPV) vaccine with no clinically relevant interference with antibody response to any of the components of either vaccine (see section 4.8).

Concomitant administration of Boostrix-IPV with other vaccines or with immunoglobulins has not been studied.

It is unlikely that co-administration will result in interference with the immune responses.

According to generally accepted vaccine practices and recommendations, if concomitant administration of Boostrix-IPV with other vaccines or immunoglobulins is considered necessary, the products should be given at separate sites.

Use with immunosuppressive treatment

As with other vaccines, patients receiving immunosuppressive therapy may not achieve an adequate response.

Pregnancy

Boostrix-IPV can be used during the second or third trimester of pregnancy in accordance with official recommendations.

For data relating to the prevention of pertussis disease in infants born to women vaccinated during pregnancy, see section 5.1.

Safety data from a randomised controlled clinical trial (341 pregnancy outcomes) and from a prospective observational study (793 pregnancy outcomes), where Boostrix (dTpa component of Boostrix-IPV) was administered to pregnant women during the third trimester, have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.

Safety data from prospective clinical studies on the use of Boostrix-IPV or Boostrix during the first and second trimester of pregnancy are not available.

Data from passive surveillance where pregnant women were exposed to Boostrix-IPV or to Boostrix in the 3rd or 2nd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the foetus/newborn child.

As with other inactivated vaccines, it is not expected that vaccination with Boostrix-IPV harms the foetus at any trimester of pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).

Breastfeeding

The effect of administration of Boostrix-IPV during lactation has not been assessed. Nevertheless, as Boostrix-IPV contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering Boostrix-IPV to breastfeeding women should carefully be evaluated by the healthcare providers.

Fertility

No human data from prospective clinical studies are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

Summary of the safety profile

The safety profile presented in Table 1 is based on data from clinical trials where Boostrix-IPV was administered to 908 children (from 4 to 8 years of age) and 955 adults, adolescents and children (from 10 to 93 years of age).

The most common events occurring after Boostrix-IPV administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3-82.3% of subjects overall. These usually had their onset within the first 48 hours after vaccination. All resolved without sequelae.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency: Very common: (≥1/10), Common: (≥1/100 to <1/10), Uncommon: (≥1/1,000 to <1/100), Rare: (≥1/10,000 to <1/1,000), Very rare: (<1/10,000)

Clinical trials

Table 1. Adverse reactions reported in clinical trials with Boostrix-IPV:

Coadministration with MMR/V vaccines in children aged 3-6 years

Boostrix-IPV was coadministered with MMR/V vaccines in 2 clinical studies with 406 children aged 3-6 years. In these studies, upper respiratory tract infection and rash were commonly reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disorders (including diarrhoea and vomiting) were reported with a higher frequency (very common) when compared to Table 1 while all other adverse reactions occurred at the same or lower frequency.

Adverse reactions additionally reported during clinical studies with Boostrix (dTpa component of Boostrix-IPV), administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age), are listed in Table 2.

Table 2. Adverse reactions reported in clinical trials with Boostrix:

Reactogenicity after repeat dose

Data suggest that in subjects primed with DTP in childhood a second booster dose might give an increase of local reactogenicity.

Subjects aged 15 years onwards without recent vaccination for diphtheria, tetanus, pertussis and poliomyelitis, who received a dose of Boostrix-IPV or another reduced-antigen content vaccine, followed by an additional dose of Boostrix-IPV 10 years after, showed no increased reactogenicity after this second dose compared to the first one.

Post-marketing surveillance

Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Table 3. Adverse reactions reported with Boostrix-IPV during post-marketing surveillance:

Following administration of tetanus toxoid containing vaccines, there have been very rare reports of adverse reactions on the central or peripheral nervous systems, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.