drugset / Trial / NCT03760146
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
RandomizedParallel-groupDouble-blindPrevention
Summary
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Timeline
- Start
- 2018-12-12
- Primary completion
- 2019-12-16
- Completion
- 2019-12-16
Outcome
Mixed primary results
paper noninferior to 13 matched serotypes after PCV13 and to 6 additional PPSV23 serotypes PMID 34940806 ↗
paper serotype 8 missed the statistical noninferiority criterion. PMID 34940806 ↗
Publications
- Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
- Essink B, Sabharwal C, Cannon K, Frenck R, Lal H, Xu X, Sundaraiyer V, Peng Y, Moyer L, Pride MW, Scully IL, Jansen KU, Gruber WC, Scott DA, Watson W. Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged >/=18 Years. Clin Infect Dis. 2022 Aug 31;75(3):390-398. doi: 10.1093/cid/ciab990.
- Mt-Isa S, Abderhalden LA, Musey L, Weiss T. Matching-adjusted indirect comparison of pneumococcal vaccines V114 and PCV20. Expert Rev Vaccines. 2022 Jan;21(1):115-123. doi: 10.1080/14760584.2021.1994858. Epub 2021 Oct 27.
- Perdrizet J, Santana CFS, Senna T, Alexandre RF, Sini de Almeida R, Spinardi J, Wasserman M. Cost-effectiveness analysis of replacing the 10-valent pneumococcal conjugate vaccine (PCV10) with the 13-valent pneumococcal conjugate vaccine (PCV13) in Brazil infants. Hum Vaccin Immunother. 2021 Apr 3;17(4):1162-1172. doi: 10.1080/21645515.2020.1809266. Epub 2020 Sep 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 13vPnC | Vaccine | — | — |
| Subject | 20vPnC | Vaccine | — | — |
| Comparator | PPSV23 | Vaccine | — | — |