NCT06838000

Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group Study to Investigate the Safety and Immunogenicity of Catch-up Vaccination Regimens of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,268 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 7 Months – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).

Detailed description

The duration of each participation will be approximately 9 to 11 months for each infant participant, 8 to 9 months for each toddler participant, and 6 months for each child/adolescent participant.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	PCV21	Investigational pneumococcal conjugate vaccine
BIOLOGICAL	20vPCV	20-valent pneumococcal conjugate vaccine

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-20
• Last updated: 2025-10-06

Locations

38 sites across 4 countries: United States, Estonia, Poland, Thailand

Regulatory

• FDA-regulated drug study