drugset / Trial / NCT04546425
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Timeline
- Start
- 2020-09-09
- Primary completion
- 2022-04-22
- Completion
- 2023-02-18
Outcome
Mixed primary results
paper One month after the toddler dose, 19/20 serotypes met NI for immunoglobulin G geometric mean concentrations; serotype 6B narrowly missed NI PMID 38456705 ↗
paper Sixteen/twenty serotypes met NI for ≥1 primary objective after 2 infant doses. PMID 38456705 ↗
release “positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425)” pfizer.com ↗
release “19 of the 20 serotypes met the NI criteria with only one serotype narrowly missing.” pfizer.com ↗
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.
- Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J, Lei L, Peng Y, Giardina PC, Gruber W, Scott D, Watson W. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024 Jun 1;43(6):587-595. doi: 10.1097/INF.0000000000004300. Epub 2024 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 13-valent pneumococcal conjugate vaccine | Vaccine | — | — |
| Subject | 20-valent pneumococcal conjugate vaccine | Vaccine | — | — |