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

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

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

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

42 Days

Max Age

89 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-18

Primary Completion

2027-10-22

Completion

2027-10-22

FDA Drug

Yes

Countries

• United States
• Honduras
• Mexico
• Puerto Rico
• Thailand
• Turkey (Türkiye)

Study Locations