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
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
2 other identifiers
interventional
580
4 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2025
CompletedFirst Posted
Study publicly available on registry
February 13, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 10, 2027
February 13, 2026
February 1, 2026
2.5 years
February 7, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Presence of any immediate adverse events (AEs)
Number of participants experiencing solicited and unsolicited immediate AEs
Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Through 7 days after each vaccine injection
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Through 30 days after each vaccine injection
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing SAEs
Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing AESIs
Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4
The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)
30 days PD4
Study Arms (4)
Group 1: 20vPCV-PCV21-PCV21-PCV21
EXPERIMENTALParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21
EXPERIMENTALParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21
EXPERIMENTALParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV
ACTIVE COMPARATORParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
Interventions
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease.
- History of seizure or significant stable or progressive neurologic disorders such as inflammatory nervous system diseases, encephalopathy, cerebral palsy
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legal acceptable representative (LAR), contraindicating intramuscular (IM) injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Previous vaccination against Streptococcus pneumoniae
- Receipt of immune globulins, blood or blood-derived products since birth
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (27)
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025
Los Angeles, California, 90027, United States
The Medici Medical Research- Site Number : 8400008
Hollywood, Florida, 33021, United States
Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027
Miami, Florida, 33135, United States
Atlantis Clinical Research- Site Number : 8400009
Miami, Florida, 33173, United States
Velocity Clinical Research - Sioux City- Site Number : 8400007
Sioux City, Iowa, 51106, United States
Private Practice - Dr. Michael W. Simon- Site Number : 8400001
Lexington, Kentucky, 40517, United States
Velocity Clinical Research - New Orleans- Site Number : 8400006
New Orleans, Louisiana, 70119, United States
Finger Lakes Medical Research - Cortland- Site Number : 8400022
Cortland, New York, 13045, United States
University of Rochester Medical Center- Site Number : 8400019
Rochester, New York, 14642, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400015
Syracuse, New York, 13210, United States
Kid's Way Pediatrics- Site Number : 8400013
Hermitage, Pennsylvania, 16148, United States
Carolina Family Care - Charleston- Site Number : 8400014
Charleston, South Carolina, 29414, United States
Helios Clinical Research - BUR PEDI- Site Number : 8400016
Burleson, Texas, 76028, United States
Clinsearch Inc at VAST Clinical Research- Site Number : 8400028
Euless, Texas, 76040, United States
DM Clinical Research - Houston - Jones Road- Site Number : 8400012
Houston, Texas, 77065, United States
University of Texas Medical Branch at Galveston- Site Number : 8400005
League City, Texas, 77555, United States
Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024
Stephenville, Texas, 76401, United States
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 8330034, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8380418, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8880465, Chile
Investigational Site Number : 4840003
León, Guanajuato, 37320, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, 04530, Mexico
Investigational Site Number : 4840002
Temixco, Morelos, 62587, Mexico
Investigational Site Number : 4840004
Tlaltizapán, Morelos, 62770, Mexico
Investigational Site Number : 6080001
Cebu City, 6000, Philippines
Investigational Site Number : 6080002
Quezon City, 1100, Philippines
Investigational Site Number : 6080003
Quezon City, 1121, Philippines
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Modified double-blind * Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff * No blinding for vaccine group assignment: those preparing and administering the study interventions
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2025
First Posted
February 13, 2025
Study Start
February 27, 2025
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
September 10, 2027
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org