drugset / Trial / NCT03828617
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Timeline
- Start
- 2019-02-14
- Primary completion
- 2019-10-09
- Completion
- 2019-10-09
Outcome
Met primary endpoint
paper Equivalence in immune responses (OPA geometric mean titers) for all 20 vaccine serotypes was demonstrated across the 3 PCV20 lots. PMID 34315611 ↗
release “Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study.” pfizer.com ↗
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.
- Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Vaccine. 2021 Sep 7;39(38):5428-5435. doi: 10.1016/j.vaccine.2021.07.004. Epub 2021 Jul 24.