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Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Sponsor: Sanofi
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
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Vaxneuvance vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hexyon vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-RvaxPro vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
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