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ACTIVE NOT RECRUITING
NCT06975878
PHASE3

Study of a 21-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 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.

Official title: 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

Key Details

Gender

All

Age Range

42 Days - 112 Days

Study Type

INTERVENTIONAL

Enrollment

1092

Start Date

2025-05-22

Completion Date

2027-08-25

Last Updated

2026-03-02

Healthy Volunteers

Yes

Interventions

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

Locations (49)

Investigational Site Number : 0560004

Alken, Belgium

Investigational Site Number : 0560001

Bruges, Belgium

Investigational Site Number : 0560002

Edegem, Belgium

Investigational Site Number : 0560005

Gozée, Belgium

Investigational Site Number : 0560007

Leuven, Belgium

Investigational Site Number : 0560003

Roeselare, Belgium

Investigational Site Number : 2030001

Jindřichův Hradec, Czechia

Investigational Site Number : 2030009

Krnov, Czechia

Investigational Site Number : 2030006

Pilsen, Czechia

Investigational Site Number : 2030008

Prague, Czechia

Investigational Site Number : 2330001

Paide, Estonia

Investigational Site Number : 2330004

Tallinn, Estonia

Investigational Site Number : 2330002

Tartu, Estonia

Investigational Site Number : 2460008

Espoo, Finland

Investigational Site Number : 2460001

Helsinki, Finland

Investigational Site Number : 2460010

Helsinki, Finland

Investigational Site Number : 2460005

Jarvenpaa, Finland

Investigational Site Number : 2460003

Kokkola, Finland

Investigational Site Number : 2460004

Oulu, Finland

Investigational Site Number : 2460002

Seinäjoki, Finland

Investigational Site Number : 2460007

Tampere, Finland

Investigational Site Number : 2460009

Turku, Finland

Investigational Site Number : 2760005

Herxheim, Germany

Investigational Site Number : 2760006

Hürth, Germany

Investigational Site Number : 2760014

Hürth, Germany

Investigational Site Number : 2760013

Krefeld, Germany

Investigational Site Number : 2760010

Mönchengladbach, Germany

Investigational Site Number : 2760012

Mönchengladbach, Germany

Investigational Site Number : 2760008

Schönau am Königssee, Germany

Investigational Site Number : 2760003

Wolfsburg, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000002

Athens, Greece

Investigational Site Number : 3000006

Ioannina, Greece

Investigational Site Number : 3000005

Thessaloniki, Greece

Investigational Site Number : 3800004

Rome, Lazio, Italy

Investigational Site Number : 3800002

Rome, Roma, Italy

Investigational Site Number : 3800001

Bari, Italy

Investigational Site Number : 3800008

Foggia, Italy

Investigational Site Number : 3800010

Lecce, Italy

Investigational Site Number : 3800007

Milan, Italy

Investigational Site Number : 3800009

Parma, Italy

Investigational Site Number : 6160001

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6160007

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6160009

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160003

Trzebnica, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160008

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160011

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160005

Łomianki, Masovian Voivodeship, Poland

Investigational Site Number : 6160002

Siemianowice Śląskie, Silesian Voivodeship, Poland