Prevenar 20 (previously Apexxnar) · 4.8 Undesirable effects · 1

HOS-099685 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Paediatric population The safety of Prevenar 20 was evaluated in 5 987 participants, 6 weeks of age to less than 18 years of age, in 5 clinical trials (one Phase 2 and four Phase 3), 4 randomised, double-blind, active-controlled 7 clinical trials and 1 single-arm clinical trial; 3 664 participants received at least 1 dose of Prevenar 20, and 2 323 participants received Prevenar 13 (control vaccine). Participants 6 weeks to less than 15 months of age Clinical trials were conducted in healthy infants 6 weeks to less than 15 months of age using a 3-dose schedule or a 4-dose schedule (see section 5.1). In these infant trials, 5 156 participants received at least 1 dose of vaccine: 2 833 received Prevenar 20, and 2 323 received Prevenar 13. Overall, approximately 90% of participants in each group received all doses through the study-specified toddler dose. In all studies, local reactions and systemic events were collected after each dose, and adverse events (AEs) were collected in all studies from the first dose through 1 month after the last infant vaccination and from the toddler dose through 1 month after the toddler dose. Serious adverse events were evaluated through 1 month after the last dose in the Phase 3 trial B7471012 (Study 1012) and through 6 months after the last dose in Phase 3 trials (Studies 1011, 1013) and Phase 2 trial (Study 1003). Prevenar 20 was well tolerated, when administered in a 3-dose and a 4-dose series, in the infant study populations with low rates of severe local reactions and systemic events, and most reactions resolving within 1 to 3 days. The percentages of participants with local reactions and systemic events after Prevenar 20 were generally similar to those after Prevenar 13. The most frequently reported local reactions and systemic events after any dose of Prevenar 20 were irritability, drowsiness, and pain at injection site. In these studies, Prevenar 20 was co-administered or permitted to be administered with certain routine paediatric vaccines (see section 4.5). Study 1012 was a pivotal, double-blind, randomised, active-controlled Phase 3 trial, in which 601 healthy infants received Prevenar 20 in a 3-dose series. The most frequently reported (> 10%) adverse reactions after any dose of Prevenar 20 were irritability (71.0% to 71.9%), drowsiness/increased sleep (50.9% to 61.2%), pain at injection site (22.8% to 42.4%), decreased appe

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HOS-099681 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.

HOS-099680 · has-indication-information · PDF-Seite 3

Active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. Prevenar 20 should be used in accordance with official recommendations.

HOS-099683 · has-interaction-information · PDF-Seite 6

Different injectable vaccines should always be administered at different vaccination sites. Do not mix Prevenar 20 with other vaccines or medicinal products in the same syringe. Paediatric population In infants and children, 6 weeks to less than 5 years of age, Prevenar 20 can be administered concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, hepatitis B, Haemophilus influenzae type b, inactivated poliomyelitis, measles, mumps, rubella, and varicella vaccines. In clinical trials, rotavirus vaccines were permitted to be administered concomitantly with Prevenar 20 and no safety concerns were observed. 6 Individuals 18 years of age and older Prevenar 20 may be administered concomitantly with seasonal influenza vaccine (QIV; surface antigen, inactivated, adjuvanted). In subjects with underlying conditions associated with a high risk of developing life-threatening pneumococcal disease, consideration may be given to separating administrations of QIV and Prevenar 20 (e.g., by approximately 4 weeks). In a double-blind, randomised study (B7471004) in adults 65 years of age and older, the immune response was formally non-inferior, however numerically lower titres were observed for all pneumococcal serotypes included in Prevenar 20 when given concomitantly with seasonal influenza vaccine (QIV, surface antigen, inactivated, adjuvanted) compared to when Prevenar 20 was given alone. The clinical relevance of this finding is unknown. Prevenar 20 can be administered concomitantly with COVID-19 mRNA vaccine (nucleoside modified). There are no data on the concomitant administration of Prevenar 20 with other vaccines.

HOS-099684 · has-pregnancy-information · PDF-Seite 7

Pregnancy There are no data on the use of Prevenar 20 in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Administration of Prevenar 20 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Prevenar 20 is excreted in human milk. Fertility No human data on the effect of Prevenar 20 on fertility are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

HOS-099682 · has-warning-information · PDF-Seite 5

Do not inject Prevenar 20 intravascularly. 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. Hypersensitivity As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Thrombocytopenia and coagulation disorders The vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration. The risk of bleeding in patients with coagulation disorders needs to be carefully evaluated before intramuscular administration of any vaccine, and subcutaneous administration should be considered if the potential benefit clearly outweighs the risks. Protection against pneumococcal disease Prevenar 20 may only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media (OM). As with any vaccine, Prevenar 20 may not protect all individuals receiving the vaccine from invasive pneumococcal disease (IPD), pneumonia or OM. For the most recent epidemiological information in your country, you should consult with the relevant national organisation. 5 Immunocompromised individuals Safety and immunogenicity data on Prevenar 20 are not available for individuals in immunocompromised groups. Vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, some individuals with altered immunocompetence may have reduced immune responses to Prevenar 20. Individuals with impaired immune response, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation. The clinical relevance of this is unknown. Safety and immunogenicity data with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Prevenar 20) are available for individuals with HIV infection,

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