drugset / Trial / NCT04382326
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Timeline
- Start
- 2020-05-20
- Primary completion
- 2022-09-02
- Completion
- 2022-09-02
Publications
- Senders S, Korbal P, Kline M, Tamimi N, Thompson A, Drozd J, Cutler MW, Giardina PC, Trammel J, Lei L, Peng Y, Watson W, McElwee K. Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants. Vaccine. 2025 Dec 5;68:127916. doi: 10.1016/j.vaccine.2025.127916. Epub 2025 Nov 3.
- Senders S, Klein NP, Tamimi N, Thompson A, Baugher G, Trammel J, Peng Y, Giardina P, Scully IL, Pride M, Center KJ, Gruber WC, Scott DA, Watson W. A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2024 Jun 1;43(6):596-603. doi: 10.1097/INF.0000000000004334. Epub 2024 Mar 26.
- Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 20-valent pneumococcal conjugate vaccine | Vaccine | — | — |
| Comparator | Prevnar 13 | Vaccine | — | — |