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Clinical Trial
. 2025 Apr 19:53:126931.
doi: 10.1016/j.vaccine.2025.126931. Epub 2025 Mar 12.

A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine

Federico Martinón-Torres  1 , Silvina Natalini Martinez  2 , Mary J Kline  3 , Jelena Drozd  4 , James Trammel  4 , Yahong Peng  4 , Peter C Giardina  5 , William C Gruber  5 , Wendy Watson  4 , Kara Bickham  5 , Noor Tamimi  4
Affiliations
Free article
Clinical Trial

A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine

Federico Martinón-Torres et al. Vaccine. .
Free article

Abstract

This phase 3, randomized, partially double-blind study investigated the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine (PCV20) in healthy toddlers ≥12-<24 months of age who had previously received 2 infant doses of 13-valent PCV (PCV13). Participants were randomized to receive 1 or 2 doses of PCV20 (the second dose was administered 56-70 days after the first dose), or 1 dose of PCV13. The primary pneumococcal immunogenicity endpoint was the percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations (≥0.35 μg/mL) for the 7 additional serotypes 1 month after the last vaccination. Percentages of participants with predefined IgG concentrations for the 13 matched serotypes, IgG geometric mean concentrations, and opsonophagocytic activity (OPA) geometric mean titers were also evaluated for all 20 vaccine serotypes. Safety endpoints included local reactions, systemic events, adverse events, and serious adverse events. Overall, 356 participants were randomized (2-dose PCV20, n = 121; 1-dose PCV20, n = 118; PCV13, n = 117). One month after 1 PCV20 dose, ≥75.9 % of participants had IgG concentrations ≥0.35 μg/mL for all 7 additional serotypes, except serotype 12F (54.6 %). After 2 PCV20 doses, the percentage of participants with IgG concentrations ≥0.35 μg/mL for the 7 additional serotypes was ≥91.2 %. PCV20 elicited IgG and OPA responses for all 20 serotypes including serotype 12F. IgG distributions were well differentiated and substantially higher in PCV20 groups than the PCV13 group for the 7 additional serotypes, and generally similar between all groups for the 13 matched serotypes. In conclusion, a single toddler dose of PCV20 after 2 infant PCV13 doses elicited immune responses expected to help provide protection against the 7 additional serotypes and to provide similar protection against the 13 matched serotypes as PCV13. These data support a transition from PCV13 to PCV20 at the toddler dose. The safety and tolerability profile of PCV20 was similar to PCV13. Trial registration:Clinicaltrials.gov, NCT05408429.

Keywords: 20-valent pneumococcal conjugate vaccine; Immunogenicity; PCV20; Safety; Toddlers.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: FMT declares that his institution received payment from Pfizer for conducting this trial, and from Ablynx, Abbot, Seqirus, Sanofi, MSD, Merck, Pfizer, Roche, Regeneron, Janssen, Medimmune, Novavax, Novartis, and GSK for other vaccine trials; FMT also reports receiving honoraria for lectures from Sanofi, MSD, Moderna, GSK, Biofabri, AstraZeneca, Novavax, Janssen, and Pfizer; payment of travel expenses and meeting fees from Pfizer, MSD, GSK, and Sanofi; and participation on data safety monitoring boards or advisory boards for Pfizer, GSK, Moderna, Sanofi, AstraZeneca, and Biofabri; FMT is also a member of WHO's European Technical Advisory Group of Experts, coordinator of the Spanish Pediatric Clinical Trials Network, and coordinator of WHO collaborating center for vaccine safety of Santiago de Compostela. SNM declares that her institution received payment from Pfizer for conducting this trial; from Sanofi, MSD, GSK, Janssen, AstraZeneca, HIPRA, and Moderna for other vaccines trials; and from GSK for participation on data safety monitoring boards or advisory boards. All other authors are current or previous employees of Pfizer and may own stock or stock options.

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