NCT06824194

Study of the Safety 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 of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,360 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Conditions

• Pneumococcal Immunization

Interventions

Type	Name	Description
BIOLOGICAL	PCV21 vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Prevnar 20 vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	M-M-R II vaccine	Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
BIOLOGICAL	Rotarix	Pharmaceutical form:Solution-Route of administration:Oral
BIOLOGICAL	RotaTeq	Pharmaceutical form:Solution-Route of administration:Oral
BIOLOGICAL	Vaxelis vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Varivax	Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
BIOLOGICAL	Priorix	Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
BIOLOGICAL	VAQTA	Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
BIOLOGICAL	Havrix	Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Timeline

• Start date: 2025-02-18
• Primary completion: 2027-10-22
• Completion: 2027-10-22
• First posted: 2025-02-13
• Last updated: 2026-04-13

Locations

132 sites across 6 countries: United States, Honduras, Mexico, Puerto Rico, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study