Beate Schmoele-Thoma, Germany
Pfizer Pharma GmbH Vaccine Clinical Research and DevelopmentAuthor Of 1 Presentation
IMMUNOGENICITY AND REACTOGENICITY OF THE 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AT INCREASED OR HIGH RISK OF PNEUMOCOCCAL DISEASE (ID 592)
- Masanori Ikeda, Japan
- Yoshitaka Yamazaki, Japan
- Takayuki Imada, Japan
- Kenji Furuno, Japan
- Yutaka Okano, Japan
- Tomoyuki Mizukami, Japan
- Richard De Solom, Australia
- Yasuko Shoji, Japan
- Motoki Oe, Japan
- Masakazu Aizawa, Japan
- Peter C. Giardina, United States of America
- Beate Schmoele-Thoma, Germany
- Dan A. Scott, United States of America
Abstract
Background
Pneumococcal disease (PD) is associated with significant disease burden among those with certain chronic medical conditions. An open-label phase 3 study evaluated the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in Japanese individuals aged 6‒64 years with increased PD risk.
Methods
Subgroup analyses of immunogenicity and reactogenicity were conducted in subjects categorized as at-risk (ie, immunocompetent but having chronic medical conditions associated with increased PD risk) or high-risk (ie, immunocompromised due to diseases/conditions and/or medications). Immune responses were measured before and 1 month after one PCV13 dose.
Results
Among subjects aged 6‒<18 years, 66.0% were categorized as at-risk and 34.0% were high-risk; percentages for those aged 18‒<65 years were 52.3% and 47.7%, respectively (Table). Opsonophagocytic activity (OPA) geometric mean fold rises from prevaccination ranged from 3.9–635.1 across subgroups, with lower limits of the 2‑sided 95% CIs >1 for all 13 serotypes (Figure 1); Immunoglobulin G results were consistent with OPA analysis. Reactogenicity events were generally mild or moderate across subgroups (Figure 2).
Conclusions
PCV13 is immunogenic and well tolerated in individuals aged 6‒64 years at risk or high risk of PD. Results were similar to past PCV13 studies in other populations. Funded by Pfizer.