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ACTIVE NOT RECRUITING
NCT06824181
PHASE3

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series 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 (MoA). 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.

Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Key Details

Gender

All

Age Range

42 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2025-02-27

Completion Date

2027-09-10

Last Updated

2026-02-13

Healthy Volunteers

Yes

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

Locations (27)

Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025

Los Angeles, California, United States

The Medici Medical Research- Site Number : 8400008

Hollywood, Florida, United States

Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027

Miami, Florida, United States

Atlantis Clinical Research- Site Number : 8400009

Miami, Florida, United States

Velocity Clinical Research - Sioux City- Site Number : 8400007

Sioux City, Iowa, United States

Private Practice - Dr. Michael W. Simon- Site Number : 8400001

Lexington, Kentucky, United States

Velocity Clinical Research - New Orleans- Site Number : 8400006

New Orleans, Louisiana, United States

Finger Lakes Medical Research - Cortland- Site Number : 8400022

Cortland, New York, United States

University of Rochester Medical Center- Site Number : 8400019

Rochester, New York, United States

SUNY Upstate Medical University - Syracuse- Site Number : 8400015

Syracuse, New York, United States

Kid's Way Pediatrics- Site Number : 8400013

Hermitage, Pennsylvania, United States

Carolina Family Care - Charleston- Site Number : 8400014

Charleston, South Carolina, United States

Helios Clinical Research - BUR PEDI- Site Number : 8400016

Burleson, Texas, United States

Clinsearch Inc at VAST Clinical Research- Site Number : 8400028

Euless, Texas, United States

DM Clinical Research - Houston - Jones Road- Site Number : 8400012

Houston, Texas, United States

University of Texas Medical Branch at Galveston- Site Number : 8400005

League City, Texas, United States

Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024

Stephenville, Texas, United States

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 4840003

León, Guanajuato, Mexico

Investigational Site Number : 4840001

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840002

Temixco, Morelos, Mexico

Investigational Site Number : 4840004

Tlaltizapán, Morelos, Mexico

Investigational Site Number : 6080001

Cebu City, Philippines

Investigational Site Number : 6080002

Quezon City, Philippines

Investigational Site Number : 6080003

Quezon City, Philippines