NCT06975878

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,092 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 42 Days – 112 Days
• Healthy volunteers: Accepted

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days). The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations. • There will be 5 (for full-term infants) or 6 (for preterm infants) study visits: * Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days. * Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 months of age, V06 separated from V05 by 30 days.

Conditions

• Pneumococcal Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	PCV21 vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Vaxneuvance vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Hexyon vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	M-M-RvaxPro vaccine	Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
BIOLOGICAL	Varivax vaccine	Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-08-25
• Completion: 2027-08-25
• First posted: 2025-05-16
• Last updated: 2026-03-02

Locations

49 sites across 8 countries: Belgium, Czechia, Estonia, Finland, Germany, Greece, Italy, Poland

Regulatory

• FDA-regulated drug study