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
Outcome
Mixed primary results
paper For IgG geometric mean concentrations 1 month after both doses 3 and 4, all 20 serotypes met NI criteria PMID 38535409 ↗
paper geometric mean ratio lower 2-sided 95% confidence interval > 0.5 PMID 38535409 ↗
paper NI (percentage differences lower 2-sided 95% confidence interval > -10%) was met for 8/13 matched serotypes and 6/7 additional serotypes PMID 38535409 ↗
paper 4 serotypes missed the statistical NI criterion by small margins. PMID 38535409 ↗
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 |
|---|---|---|---|---|
| Comparator | 13-valent pneumococcal conjugate vaccine | Vaccine | — | — |
| Subject | 20-valent pneumococcal conjugate vaccine | Vaccine | — | — |