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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
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
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
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PP-UNP-IRL-0176. January 2023