Session Type: ePosters
Session Title: ePosters
Authors(s): K. Cannon (1), C. Elder (2), M. Young (3), D.A. Scott (3), I.L. Scully (3), G. Baugher (3), Y. Peng (3), K.U. Jansen (3), W.C. Gruber (3), W. Watson (3)
Authors Affiliations(s): (1) PMG Research of Wilmington, LLC, United States, (2) Kaiser Permanente Center for Health Research, United States, (3) Vaccine Research and Development, Pfizer Inc, United States
Background:
The 20-valent pneumococcal conjugate vaccine (PCV20) has been developed to expand protection against pneumococcal disease beyond that provided by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent PCV (PCV13). Given that older adults may be pneumococcal vaccine–experienced, it is important to describe the safety and immunogenicity of PCV20 in this population.
Methods:This phase 3, multicenter, randomised, open-label study was conducted in the United States and Sweden and enrolled adults ≥65 years of age into 1 of 3 cohorts based on their previous pneumococcal vaccination history (ClinicalTrials.gov NCT03835975). Participants with prior PPSV23 only were randomised to receive PCV20 or PCV13, prior PCV13 only were randomised to receive PCV20 or PPSV23, and prior PCV13 and PPSV23 were all to receive PCV20. A single dose was administered; PCV13 and PPSV23 served as safety controls. Local and systemic reactions were assessed for 10 and 7 days after vaccination, respectively. Adverse events (AEs) were collected for 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) for 6 months after vaccination. Serotype-specific opsonophagocytic activity (OPA) titres for PCV20 were measured before and 1 month after vaccination.
Results:A total of 375 participants with prior PPSV23, 375 participants with prior PCV13, and 125 participants with both PCV13 and PPSV23 were enrolled. The percentages of participants reporting local and systemic reactions after PCV20 were similar across the 3 cohorts, and were similar to the percentages in the safety controls; most reactions were mild or moderate. Rates of AEs, SAEs, and NDCMCs were low across all groups. Regardless of prior pneumococcal vaccination, immune responses were observed to the 20 vaccine serotypes as assessed by OPA geometric mean titres, OPA geometric mean fold rises, and the percentage of participants with ≥4-fold rise in OPA titres from before to 1 month after PCV20.
Conclusions:The safety and tolerability of PCV20 are similar across individuals with different pneumococcal vaccine histories and are similar to PCV13 and PPSV23. PCV20 elicits immune responses against the 20 vaccine serotypes in adults ≥65 years of age regardless of previous pneumococcal vaccination.
Keyword(s): pneumococcal conjugate vaccine, safety, immunogenicityCOI Other: Kevin Cannon and Charles Elder report no conflict of interest. Mariano Young, Daniel A. Scott, Ingrid L. Scully, Gary Baugher, Yahong Peng, Kathrin U. Jansen, William C. Gruber, and Wendy Watson are employees of Pfizer Inc and may hold stock and/or stock options.
Session Type: ePosters
Session Title: ePosters
Authors(s): K. Cannon (1), C. Elder (2), M. Young (3), D.A. Scott (3), I.L. Scully (3), G. Baugher (3), Y. Peng (3), K.U. Jansen (3), W.C. Gruber (3), W. Watson (3)
Authors Affiliations(s): (1) PMG Research of Wilmington, LLC, United States, (2) Kaiser Permanente Center for Health Research, United States, (3) Vaccine Research and Development, Pfizer Inc, United States
Background:
The 20-valent pneumococcal conjugate vaccine (PCV20) has been developed to expand protection against pneumococcal disease beyond that provided by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent PCV (PCV13). Given that older adults may be pneumococcal vaccine–experienced, it is important to describe the safety and immunogenicity of PCV20 in this population.
Methods:This phase 3, multicenter, randomised, open-label study was conducted in the United States and Sweden and enrolled adults ≥65 years of age into 1 of 3 cohorts based on their previous pneumococcal vaccination history (ClinicalTrials.gov NCT03835975). Participants with prior PPSV23 only were randomised to receive PCV20 or PCV13, prior PCV13 only were randomised to receive PCV20 or PPSV23, and prior PCV13 and PPSV23 were all to receive PCV20. A single dose was administered; PCV13 and PPSV23 served as safety controls. Local and systemic reactions were assessed for 10 and 7 days after vaccination, respectively. Adverse events (AEs) were collected for 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) for 6 months after vaccination. Serotype-specific opsonophagocytic activity (OPA) titres for PCV20 were measured before and 1 month after vaccination.
Results:A total of 375 participants with prior PPSV23, 375 participants with prior PCV13, and 125 participants with both PCV13 and PPSV23 were enrolled. The percentages of participants reporting local and systemic reactions after PCV20 were similar across the 3 cohorts, and were similar to the percentages in the safety controls; most reactions were mild or moderate. Rates of AEs, SAEs, and NDCMCs were low across all groups. Regardless of prior pneumococcal vaccination, immune responses were observed to the 20 vaccine serotypes as assessed by OPA geometric mean titres, OPA geometric mean fold rises, and the percentage of participants with ≥4-fold rise in OPA titres from before to 1 month after PCV20.
Conclusions:The safety and tolerability of PCV20 are similar across individuals with different pneumococcal vaccine histories and are similar to PCV13 and PPSV23. PCV20 elicits immune responses against the 20 vaccine serotypes in adults ≥65 years of age regardless of previous pneumococcal vaccination.
Keyword(s): pneumococcal conjugate vaccine, safety, immunogenicityCOI Other: Kevin Cannon and Charles Elder report no conflict of interest. Mariano Young, Daniel A. Scott, Ingrid L. Scully, Gary Baugher, Yahong Peng, Kathrin U. Jansen, William C. Gruber, and Wendy Watson are employees of Pfizer Inc and may hold stock and/or stock options.
Session Type: ePosters
Session Title: ePosters
Authors(s): K. Cannon (1), C. Elder (2), M. Young (3), D.A. Scott (3), I.L. Scully (3), G. Baugher (3), Y. Peng (3), K.U. Jansen (3), W.C. Gruber (3), W. Watson (3)
Authors Affiliations(s): (1) PMG Research of Wilmington, LLC, United States, (2) Kaiser Permanente Center for Health Research, United States, (3) Vaccine Research and Development, Pfizer Inc, United States
Background:
The 20-valent pneumococcal conjugate vaccine (PCV20) has been developed to expand protection against pneumococcal disease beyond that provided by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent PCV (PCV13). Given that older adults may be pneumococcal vaccine–experienced, it is important to describe the safety and immunogenicity of PCV20 in this population.
Methods:This phase 3, multicenter, randomised, open-label study was conducted in the United States and Sweden and enrolled adults ≥65 years of age into 1 of 3 cohorts based on their previous pneumococcal vaccination history (ClinicalTrials.gov NCT03835975). Participants with prior PPSV23 only were randomised to receive PCV20 or PCV13, prior PCV13 only were randomised to receive PCV20 or PPSV23, and prior PCV13 and PPSV23 were all to receive PCV20. A single dose was administered; PCV13 and PPSV23 served as safety controls. Local and systemic reactions were assessed for 10 and 7 days after vaccination, respectively. Adverse events (AEs) were collected for 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) for 6 months after vaccination. Serotype-specific opsonophagocytic activity (OPA) titres for PCV20 were measured before and 1 month after vaccination.
Results:A total of 375 participants with prior PPSV23, 375 participants with prior PCV13, and 125 participants with both PCV13 and PPSV23 were enrolled. The percentages of participants reporting local and systemic reactions after PCV20 were similar across the 3 cohorts, and were similar to the percentages in the safety controls; most reactions were mild or moderate. Rates of AEs, SAEs, and NDCMCs were low across all groups. Regardless of prior pneumococcal vaccination, immune responses were observed to the 20 vaccine serotypes as assessed by OPA geometric mean titres, OPA geometric mean fold rises, and the percentage of participants with ≥4-fold rise in OPA titres from before to 1 month after PCV20.
Conclusions:The safety and tolerability of PCV20 are similar across individuals with different pneumococcal vaccine histories and are similar to PCV13 and PPSV23. PCV20 elicits immune responses against the 20 vaccine serotypes in adults ≥65 years of age regardless of previous pneumococcal vaccination.
Keyword(s): pneumococcal conjugate vaccine, safety, immunogenicityCOI Other: Kevin Cannon and Charles Elder report no conflict of interest. Mariano Young, Daniel A. Scott, Ingrid L. Scully, Gary Baugher, Yahong Peng, Kathrin U. Jansen, William C. Gruber, and Wendy Watson are employees of Pfizer Inc and may hold stock and/or stock options.
Session Type: ePosters
Session Title: ePosters
Authors(s): K. Cannon (1), C. Elder (2), M. Young (3), D.A. Scott (3), I.L. Scully (3), G. Baugher (3), Y. Peng (3), K.U. Jansen (3), W.C. Gruber (3), W. Watson (3)
Authors Affiliations(s): (1) PMG Research of Wilmington, LLC, United States, (2) Kaiser Permanente Center for Health Research, United States, (3) Vaccine Research and Development, Pfizer Inc, United States
Background:
The 20-valent pneumococcal conjugate vaccine (PCV20) has been developed to expand protection against pneumococcal disease beyond that provided by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent PCV (PCV13). Given that older adults may be pneumococcal vaccine–experienced, it is important to describe the safety and immunogenicity of PCV20 in this population.
Methods:This phase 3, multicenter, randomised, open-label study was conducted in the United States and Sweden and enrolled adults ≥65 years of age into 1 of 3 cohorts based on their previous pneumococcal vaccination history (ClinicalTrials.gov NCT03835975). Participants with prior PPSV23 only were randomised to receive PCV20 or PCV13, prior PCV13 only were randomised to receive PCV20 or PPSV23, and prior PCV13 and PPSV23 were all to receive PCV20. A single dose was administered; PCV13 and PPSV23 served as safety controls. Local and systemic reactions were assessed for 10 and 7 days after vaccination, respectively. Adverse events (AEs) were collected for 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) for 6 months after vaccination. Serotype-specific opsonophagocytic activity (OPA) titres for PCV20 were measured before and 1 month after vaccination.
Results:A total of 375 participants with prior PPSV23, 375 participants with prior PCV13, and 125 participants with both PCV13 and PPSV23 were enrolled. The percentages of participants reporting local and systemic reactions after PCV20 were similar across the 3 cohorts, and were similar to the percentages in the safety controls; most reactions were mild or moderate. Rates of AEs, SAEs, and NDCMCs were low across all groups. Regardless of prior pneumococcal vaccination, immune responses were observed to the 20 vaccine serotypes as assessed by OPA geometric mean titres, OPA geometric mean fold rises, and the percentage of participants with ≥4-fold rise in OPA titres from before to 1 month after PCV20.
Conclusions:The safety and tolerability of PCV20 are similar across individuals with different pneumococcal vaccine histories and are similar to PCV13 and PPSV23. PCV20 elicits immune responses against the 20 vaccine serotypes in adults ≥65 years of age regardless of previous pneumococcal vaccination.
Keyword(s): pneumococcal conjugate vaccine, safety, immunogenicityCOI Other: Kevin Cannon and Charles Elder report no conflict of interest. Mariano Young, Daniel A. Scott, Ingrid L. Scully, Gary Baugher, Yahong Peng, Kathrin U. Jansen, William C. Gruber, and Wendy Watson are employees of Pfizer Inc and may hold stock and/or stock options.