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AboutAboutAbout APEXXNARMechanism of actionClinical programmeClinical programmeAPEXXNAR clinical study overviewAPEXXNAR adverse drug reactionsAdministration
APEXXNAR® was evaluated for safety and immunogenicity across a diverse patient population1

The safety of APEXXNAR was evaluated in 4,552 participants 18 years of age and older in six clinical trials (two Phase 1, one Phase 2, and three Phase 3)1

Studied in pneumococcal vaccine-naïve and previously vaccinated adults1Pneumococcal vaccine-naïveStudy design: Pneumococcal vaccine-naïve adults aged 18 years or older1 Study results: Pneumococcal vaccine-naïve adults aged 18 years or older1

Demonstrated noninferior immunogenicity* compared to Prevenar 13® and PPV23 for most shared serotypes1

Noninferiority for a particular serotype was declared if the lower bound of the 2-sided 95% CI for the GMT ratio (APEXXNAR/Prevenar 13; APEXXNAR/PPV23) for that serotype was >0.5.1

Immunogenicity for 20 serotypes in APEXXNAR measured in vaccine-naïve adults aged 60 years or older1

The immune responses in adults aged 18-49 years and in adults aged 50-59 years were compared to the immune response to the corresponding serotype-specific immune responses in adults aged 60-64 years following APEXXNAR.1

OPA GMTs 1 month after vaccination with APEXXNAR.Previously received pneumococcal vaccinationStudy design: Previously vaccinated adults aged 65 years or older1 Study results: Previously vaccinated adults aged 65 years or older1

All cohort participants were previously vaccinated with either PPV23, Prevenar 13®, or Prevenar 13 followed by PPV23. A single dose of APEXXNAR was administered in each cohort and demonstrated to be well tolerated and immunogenic regardless of previous pneumococcal vaccination status.1

OPA GMTs in participants who received PPV23 ≥1 to ≤5 years prior were reduced compared to participants who received Prevenar 13 at least 6 months prior and compared to participants who received Prevenar 13 followed by PPV23 with the last PPV23 dose at least 1 year prior.1

This randomised, open-label clinical trial described immune responses to APEXXNAR in adults aged 65 years or older previously vaccinated with PPV23, Prevenar 13, or Prevenar 13 followed by PPV23.1

CI=confidence interval; GMT=geometric mean titre; IPD=invasive pneumococcal disease; OPA=opsonophagocytic activity; PCV13=Prevenar 13® (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]); PPV23=23-valent pneumococcal polysaccharide vaccine.▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 for how to report adverse reactions.References:APEXXNAR® Summary of Product Characteristics.ClinicalTrials.gov. Trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults. Available at: https://clinicaltrials.gov/ct2/show/NCT03760146. Last Accessed: August 2022ClinicalTrials.gov. Trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal vaccine in adults 65 years of age or older with prior pneumococcal vaccination. Available at: https://clinicaltrials.gov/ct2/show/NCT03835975. Last Accessed: August 2022ClinicalTrials.gov. Trial to evaluate the safety and immunogenicity of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults. Available at:https://clinicaltrials.gov/ct2/show/NCT03828617. Last Accessed: August 2022Clinical programme View Summary of Product Characteristics    Apexxnar® Loading Prevenar 13®

Legal Category: S1A
Further information is available upon request

PP-PNR-IRL-0016 Date of Preparation: August 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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