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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3 months
Healthy Volunteers: t
View:

• Aged 42 to 112 days on the day of inclusion

• Participants who are healthy as determined by medical evaluation including medical history and physical examination

• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator

Locations
United States
Texas
Investigational Site Number : 2460001
RECRUITING
Houston
Other Locations
Belgium
Investigational Site Number : 0560004
RECRUITING
Alken
Investigational Site Number : 0560002
RECRUITING
Edegem
Investigational Site Number : 0560005
RECRUITING
Gozée
Investigational Site Number : 0560003
RECRUITING
Roeselare
Bulgaria
Investigational Site Number : 2760010
RECRUITING
Sofia
Estonia
Investigational Site Number : 2330001
RECRUITING
Paide
Investigational Site Number : 2330004
RECRUITING
Tallinn
Investigational Site Number : 2330002
RECRUITING
Tartu
Finland
Investigational Site Number : 2460009
RECRUITING
Turku
Germany
Investigational Site Number : 6160003
RECRUITING
Berlin
Investigational Site Number : 2760005
RECRUITING
Herxheim
Investigational Site Number : 2760006
RECRUITING
Hürth
Investigational Site Number : 2760014
RECRUITING
Hürth
Investigational Site Number : 2760013
RECRUITING
Krefeld
Investigational Site Number : 2760012
RECRUITING
Mönchengladbach
Investigational Site Number : 2760008
RECRUITING
Schönau Am Königssee
Investigational Site Number : 2760003
RECRUITING
Wolfsburg
Italy
Investigational Site Number : 3800001
RECRUITING
Bari
Investigational Site Number : 3800008
RECRUITING
Foggia
Investigational Site Number : 3800010
RECRUITING
Lecce
Investigational Site Number : 3800009
RECRUITING
Parma
Poland
Investigational Site Number : 6160001
RECRUITING
Bydgoszcz
Investigational Site Number : 6160005
RECRUITING
Dziekanów Leśny
Investigational Site Number : 6160009
RECRUITING
Krakow
Investigational Site Number : 6160002
RECRUITING
Siemianowice Śląskie
Investigational Site Number : 6160007
RECRUITING
Torun
Investigational Site Number : 6160011
RECRUITING
Warsaw
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-08-18
Participants
Target number of participants: 1080
Treatments
Experimental: Group 1: PCV21
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
Active_comparator: Group 2: 15vPCV
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov