Leitlinien & Arzneimittelsicherheit

HOS-099137 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The safety of MenQuadfi presented in the tables below is based on three clinical datasets: • For children, adolescents, adults, and older adults, a pooled analysis of data from 4 919 participants who received a single dose of MenQuadfi either as a primary dose (N = 4 517) or a booster dose (N = 402). This included 498 children aged 2 through 9 years; 2 289 adolescents aged 10 through 17 years; 1 684 adults aged 18 through 55 years; 199 older adults aged 56 through 64 years; and 249 elderly aged ≥ 65 years. Of these, 392 adolescents received MenQuadfi co-administered with Tdap and 4vHPV. • A pooled analysis of 1 389 toddlers aged 12 through 23 months of age who received a single dose of MenQuadfi. Of these, 589 toddlers received MenQuadfi co-administered with MMR+V (N = 189), DTaP-IPV-HepB-Hib (N = 200) or PCV13 (N = 200). • A pooled analysis of data from 6 060 infants initiating vaccination from 6 weeks through 11 months of age who received at least one dose of a primary series consisting of one, two or three primary doses of MenQuadfi of which 5 373 toddlers received a booster dose from 12 through 18 months of age. MenQuadfi was co-administered with routine paediatric vaccines. Rates of adverse reactions after a booster dose of MenQuadfi in participants from 12 months of age and older were comparable to those seen in participants who received a primary dose of MenQuadfi. When MenQuadfi was co-administered with routine paediatric and adolescent vaccines, the safety profiles of the vaccines were comparable to those observed when they were given alone or with a different meningococcal serogroup A, C, W, Y vaccine, except: • Overall, rates of adverse reactions were higher in toddlers aged 12-23 months of age who received PCV13 given concomitantly with MenQuadfi (36.5%) than in toddlers who received PCV13 alone (17.2%). • Rates of injection site pain at the 9vHPV injection site were higher when children and adolescents aged 10-17 years of age were given MenQuadfi concomitantly with the first dose of Tdap-IPV (83.6%) compared to when Tdap-IPV and 9vHPV were given without MenQuadfi (67.3%). • Higher rates and intensity of solicited adverse reactions were observed in participants aged 12 to 13 months and 13 to 26 years of age. Higher rates of unsolicited adverse reactions were observed in parti

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HOS-099133 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or after previous administration of the vaccine or a vaccine containing the same components.

HOS-099132 · has-indication-information · PDF-Seite 2

MenQuadfi is indicated for active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations.

HOS-099135 · has-interaction-information · PDF-Seite 5

Use with other vaccines Injection sites on separate limbs and separate syringes must be used in the case of concomitant administration. In infants, MenQuadfi can be co-administered with combined diphtheria - tetanus - acellular pertussis (DTaP) – inactivated poliovirus (IPV) – hepatitis B (HepB) – Haemophilus influenzae type b (Hib, in which the Hib component is conjugated to tetanus protein) vaccine (DTaP-IPV-HepB-Hib), rotavirus vaccine (live attenuated) and with 10-valent pneumococcal conjugate vaccine (PCV10). In toddlers aged 12-23 months, MenQuadfi can be co-administered with the measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), DTaP vaccines, including combination DTaP vaccines with IPV, HepB, and Hib such as DTaP-IPV-HepB-Hib (Hib conjugated to tetanus toxoid) vaccine, PCV10, and 13-valent pneumococcal polysaccharide conjugated vaccine (PCV13). When MenQuadfi was administered concomitantly with PCV13 in toddlers aged 12-23 months, lower hSBA GMTs on day 30 post-dose for serogroup A were observed. The clinical relevance of this observation is unknown. As a precaution in toddlers initiating MenQuadfi vaccination at 12-23 months of age and who are at high risk for serogroup A disease, consideration might be given for administration of MenQuadfi and PCV13 vaccines separately. 5 There was no impact on the immune response to MenQuadfi when a meningococcal serogroup B vaccine was co-administered at 12 months of age and older. For ages 10-17 years, MenQuadfi can be co-administered with diphtheria, tetanus, pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (Tdap), or Tdap and IPV (Tdap-IPV), and 4- valent human papillomavirus vaccine (recombinant, adsorbed) (4vHPV) or 9valent HPV vaccine (9vHPV). However, the antibody responses to some of the antigens might be affected by the co- administration. Meningococcal vaccine-naïve children and adolescents aged 10-17 years had non inferior response for PT and lower antibody responses to FHA, PRN and FIM when Tdap vaccine was administered concomitantly with MenQuadfi and 4vHPV compared to co-administration with 4vHPV vaccine alone (immune response assessed after the full series of HPV was completed). The clinical implications of the observed pertussis antigen responses also observed with other quadrivalent meningococcal conjugate vaccines are unknown. The co-administration of MenQuadfi with Tdap-IPV and 9vHPV in

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HOS-099136 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is limited amount of data on the use of MenQuadfi in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). MenQuadfi should be used during pregnancy only if the expected benefits for the mother outweigh the potential risks, including those for the foetus. Breast-feeding It is unknown whether MenQuadfi is excreted in human milk. MenQuadfi should only be used during breast-feeding when the possible advantages outweigh the potential risks. Fertility 6 A developmental and reproductive toxicity study was performed in female rabbits. There were no effects on mating performances or female fertility. No study was conducted on male fertility (see section 5.3).

HOS-099134 · has-warning-information · PDF-Seite 3

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. MenQuadfi should not be administered subcutaneously, intravascularly or intradermally. It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. Hypersensitivity As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine. Intercurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination. Syncope 3 Syncope (fainting) and other anxiety‐related reactions can occur following or even before any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling or injury and to manage syncope. Thrombocytopenia and coagulation disorders MenQuadfi should be given with caution to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration. Protection MenQuadfi will only protect against Neisseria meningitidis groups A, C, W, and Y. The vaccine will not protect against any other Neisseria meningitidis groups. As with any vaccine, vaccination with MenQuadfi may not protect all vaccine recipients. Waning of serum bactericidal antibody titres against serogroup A when using human complement in the assay (hSBA) has been reported for MenQuadfi and other quadrivalent meningococcal vaccines. The clinical relevance of this observation is unknown. However, if an individual is expected to be at particular risk of exposure to serogroup A and received a dose of MenQuadfi more than approximately one year previously, consideration may be given to administering a booster dose. Lower hSBA geometric mean titres (GMTs) against serogroup A have been observed after a single dose of MenQuadfi was administered to toddlers who previously received serogroup C meningococcal conjugate vaccine (MenC-CRM) during infancy. Nevertheless, seroprotection rates were

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