Nimenrix® powder and solvent for solution for injection in pre-filled syringe.

Meningococcal groups A, C, W-135 and Y conjugate vaccine.

ABBREVIATED PRESCRIBING INFORMATION – IRELAND

Please refer to the Summary of Product Characteristics (SmPC) before prescribing Nimenrix.

Presentation: After reconstitution one dose (0.5 ml) contains 5 μg Neisseria meningitidis group A polysaccharide, 5 μg Neisseria meningitidis group C polysaccharide, 5 μg Neisseria meningitidis group W-135 polysaccharide and 5 μg Neisseria meningitidis group Y polysaccharide each conjugated to a total of 44 μg of tetanus toxoid carrier protein.

Indications: Active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135 and Y.

Dosage and Administration: For intramuscular injection only.

Primary immunisation:

Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.

Infants from 6 months of age, children, adolescents and adults: a single 0.5 ml dose should be administered. An additional primary dose of Nimenrix may be considered appropriate for some individuals.

Booster doses: After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Nimenrix vaccination. In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine.

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions for use: Never administer intravascularly, intradermally or subcutaneously. Appropriate medical treatment should always be readily available in case of anaphylactic reactions following administration of the vaccine. Postpone vaccination in acute severe febrile illness. 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. Bleeding may occur following intramuscular administration to individuals with thrombocytopenia or any coagulation disorders. In patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. Individuals with familial complement deficiencies (for example, C5 or C3 deficiencies) and patients receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135and Y, even if they develop antibodies following vaccination with Nimenrix. Immuneresponses in infants and in toddlers aged 12-14 months: In Study MenACWY-TT-083, the first dose was administered at 6 to 12 weeks, a second dose after a 2 month interval and a third (booster) dose at 12 months. DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine were co‑administered. Nimenrix elicited rabbit complement serum bactericidal assay (rSBA) and human complement serum bactericidal assay (hSBA) titres against the four meningococcal groups. The response against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines in terms of percentages with rSBA titres ≥8 at 1 month after the second dose. These data support the extrapolation of the immunogenicity data and posology to infants from 12 weeks to less than 6 months of age. In Study MenACWY-TT-087, infants received either a single primary dose at 6 months followed by a booster dose at 15-18 months (DTaP-IPV/Hib and 10-valent pneumococcal conjugate vaccine was co-administered at both vaccination time points) or three primary doses at 2, 4, and 6 months followed by a booster dose at 15-18 months. A single primary dose administered at 6 months of age elicited robust rSBA titres to the four meningococcal groups, as measured by the percentage of subjects with rSBA titres ≥8, that were comparable to responses after the last dose of a three-dose primary series. A booster dose produced robust responses, comparable between the two dosing groups, against all four meningococcal groups. A single dose administered at 6 months was associated with lower hSBA titres to groups W-135 and Y compared with three doses administered at 2, 4, and 6 months. After a booster dose, the hSBA titres to all four meningococcal groups were comparable between the two dosing schedules. Study MenACWY-TT-104 evaluated the immunogenicity after 1 month and the persistence of the response up to 5 years following 1 or 2 doses (given 2 months apart) of Nimenrix in toddlers aged 12 to 14 months. One month following one or two doses Nimenrix elicited rSBA titres against all four meningococcal groups that were similar in terms of the percentage of subjects with rSBA titre ≥8 and GMT. One month post dose one or two Nimenrix elicited hSBA titres against groups W-135 and Y that were higher in terms of the percentage of subjects with hSBA titre ≥8 when two doses were given compared with one. Nimenrix elicited hSBA titres against groups A and C that were similar in terms of the percentage of subjects with hSBA titre ≥8 when two doses were given compared with one. At Year 5 only a small difference in antibody persistence between one and two doses was observed, in terms of percentages of subjects with hSBA titres ≥8 against all groups. Antibody persistence was observed at Year 5 against groups C, W-135 and Y. The clinical relevance of the findings is unknown. If an infant aged 6 to less than 12 months of age or a toddler is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and/or Y, consideration may be given to administering a second dose of Nimenrix after an interval of 2 months. Immunogenicity in children aged 2-10 years: A single dose of Nimenrix has been demonstrated to be non-inferior to another licensed MenC-CRM vaccine in terms of vaccine response to group C and also non-inferior to the licensed ACWY-PS vaccine in terms of vaccine response to the four meningococcal groups in children aged 2-10 years. Immunogenicity in adolescents aged 11-17 years and in adults aged ≥18: Nimenrix was demonstrated to be immunologically non-inferior to the ACWY-PS vaccine in terms of vaccine response following a single dose in two clinical studies conducted in adolescents 11-17 years of age and in adults 18-55 years of age. Children (2-17 years) with anatomical or functional asplenia: Comparison of immune responses to two doses of Nimenrix given 2 months apart between 43 subjects with anatomic or functional asplenia and 43 age-matched subjects with normal splenic function demonstrated similar percentages of subjects in the two groups with rSBA titres ≥8 and ≥128 and hSBA titres ≥4 and ≥8. Immunogenicity following two doses of Nimenrix at 3 and 12 months of age: A single primary dose administered at 3 months of age elicited robust rSBA titres to the four meningococcal groups, as measured by the percentage of subjects with rSBA titres ≥ 8 and GMTs. A booster dose at 12 months of age produced robust responses against all four meningococcal groups.

Fertility, pregnancy and lactation: Vaccination during pregnancy/ lactation may be considered when the possible advantages outweigh the potential risk.

Undesirable effects: See SmPC for full details. Very common (≥1/10) adverse events are appetite loss, irritability, drowsiness, headache, fever, swelling, pain and redness at injection site, fatigue. Common (≥1/100 to <1/10) adverse events are diarrhoea, vomiting, nausea, injection site haematoma. Uncommon (≥1/1000 to <1/100) adverse events are hypersensitivity, insomnia, crying, hypoaesthesia, dizziness, pruritus, urticaria, rash, myalgia, pain in extremity, malaise, injection site induration, injection site pruritus, injection site warmth and injection site anaesthesia. Rare (≥1/10,000 to <1/1,000) adverse events are febrile convulsion. Adverse events with frequency not known are anaphylaxis and extensive limb swelling at the injection site. Please refer to the SmPC for more information on undesirable effects.

Legal category: S1A Marketing Authorisation Number: EU/1/12/767/003 Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland Unlimited Company, The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, Ireland. Ph + 353 1 4676500.

Date of preparation: 09/2024

Ref: NI 7_0