Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
2 other identifiers
interventional
2,360
6 countries
132
Brief Summary
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine 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. 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
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 22, 2027
April 13, 2026
April 1, 2026
2.7 years
February 7, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Group 1: PCV21
EXPERIMENTALParticipants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA
Group 2: 20vPCV
ACTIVE COMPARATORParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA
Interventions
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:Solution-Route of administration:Oral
Pharmaceutical form:Solution-Route of administration:Oral
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
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, 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
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal acceptable representative (LAR(s)), 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
- Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
- Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against S. pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (132)
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013
Birmingham, Alabama, 35205, United States
University of Alabama at Birmingham- Site Number : 8400130
Birmingham, Alabama, 35233, United States
Lakeview Clinical Research- Site Number : 8400054
Guntersville, Alabama, 35976, United States
Midway Medical Clinic- Site Number : 8400091
Oneonta, Alabama, 35121, United States
Noble Clinical Research- Site Number : 8400121
Tucson, Arizona, 85704, United States
The Children's Clinic- Site Number : 8400079
Jonesboro, Arkansas, 72401, United States
Helios CR, Inc. - Little Rock- Site Number : 8400090
Sherwood, Arkansas, 72120, United States
Helping Hands Healthcare Group - Fullerton- Site Number : 8400063
Fullerton, California, 92831, United States
Advanced Investigative Medicine- Site Number : 8400055
Hawthorne, California, 90250, United States
Century Research Institute- Site Number : 8400118
Huntington Park, California, 90255, United States
Matrix Clinical Research - Huntington Park- Site Number : 8400117
Huntington Park, California, 90255, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400026
Los Angeles, California, 90057, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400123
Los Angeles, California, 90057, United States
Alliance Research Institute - Lynwood- Site Number : 8400099
Lynwood, California, 90262, United States
Madera Family Medical Group- Site Number : 8400011
Madera, California, 93637, United States
FOMAT-Golden Valley Health Centers- Site Number : 8400084
Merced, California, 95340, United States
Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072
Palo Alto, California, 94304, United States
Center for Clinical Trials - Paramount- Site Number : 8400100
Paramount, California, 90723, United States
Integrated Clinical Research LLC- Site Number : 8400027
Sherman Oaks, California, 91356-4173, United States
Emanate Health - Queen of the Valley Hospital- Site Number : 8400105
West Covina, California, 91790, United States
All In One Clinic- Site Number : 8400127
Whittier, California, 90601, United States
Amicis Research Center-Winnetka- Site Number : 8400128
Winnetka, California, 91306, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102
Washington D.C., District of Columbia, 20009, United States
D&H Doral Research Center- Site Number : 8400095
Doral, Florida, 33122, United States
Dolphin Medical Research, LLC- Site Number : 8400120
Doral, Florida, 33172, United States
Nextlevel Research Center- Site Number : 8400065
Doral, Florida, 33172, United States
CuraCare- Site Number : 8400125
Kendall, Florida, 33176, United States
PAS RESEARCH-Lutz- Site Number : 8400103
Lutz, Florida, 33549, United States
Abba Medical Research- Site Number : 8400064
Miami, Florida, 33176, United States
D&H National Research Center- Site Number : 8400085
North Miami, Florida, 33169, United States
Alfa Medical Research LLC- Site Number : 8400111
Pembroke Pines, Florida, 33029, United States
PAS Research - Tampa- Site Number : 8400113
Tampa, Florida, 33613, United States
Morehouse School of Medicine - Atlanta- Site Number : 8400093
Atlanta, Georgia, 30310, United States
CenExel - iResearch - Savannah- Site Number : 8400057
Savannah, Georgia, 31405, United States
Bingham Memorial Hospital - Blackfoot- Site Number : 8400114
Blackfoot, Idaho, 83221, United States
Elite Clinical Trials - Blackfoot- Site Number : 8400017
Blackfoot, Idaho, 83221, United States
Clinical Research Prime- Site Number : 8400022
Idaho Falls, Idaho, 83404, United States
Eagle Clinical Research- Site Number : 8400087
Chicago, Illinois, 60621, United States
University of Chicago Medical Center- Site Number : 8400062
Chicago, Illinois, 60637, United States
MidValley Research - Moline- Site Number : 8400096
Moline, Illinois, 61265, United States
South Bend Clinic - Main Campus- Site Number : 8400023
South Bend, Indiana, 46617, United States
Integrated Clinical Trial Services- Site Number : 8400059
West Des Moines, Iowa, 50265, United States
Kentucky Pediatric Research- Site Number : 8400014
Bardstown, Kentucky, 40004, United States
University of Kentucky Chandler Medical Center- Site Number : 8400034
Lexington, Kentucky, 40536, United States
Novak Center For Children's Health- Site Number : 8400073
Louisville, Kentucky, 40202, United States
Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056
Louisville, Kentucky, 40243, United States
Velocity Clinical Research - Lafayette- Site Number : 8400046
Lafayette, Louisiana, 70508, United States
NOLA Research Works- Site Number : 8400035
New Orleans, Louisiana, 70125, United States
The Pediatric Center- Site Number : 8400075
Columbia, Maryland, 21045, United States
The Pediatric Center of Frederick- Site Number : 8400074
Frederick, Maryland, 21702, United States
Virgo Carter Pediatrics- Site Number : 8400001
Silver Spring, Maryland, 20910, United States
Michigan Institute of Research- Site Number : 8400131
Allen Park, Michigan, 48101, United States
Vida Clinical Studies - Dearborn- Site Number : 8400094
Dearborn, Michigan, 48124, United States
Clinical Research Institute - Minneapolis- Site Number : 8400002
Minneapolis, Minnesota, 55402, United States
Jefferson City Medical Group- Site Number : 8400129
Jefferson City, Missouri, 65109, United States
Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019
Lincoln, Nebraska, 68504, United States
Midwest Children's Health Research Institute- Site Number : 8400016
Lincoln, Nebraska, 68505, United States
Be Well Clinical Studies - Lincoln- Site Number : 8400031
Lincoln, Nebraska, 68516, United States
Midwest Childrens Health Research Institute- Site Number : 8400021
Lincoln, Nebraska, 68516, United States
Midwest Children's Health Research Institute - Lincoln - West A Street- Site Number : 8400045
Lincoln, Nebraska, 68522, United States
PAS Research - Henderson- Site Number : 8400033
Henderson, Nevada, 89014, United States
SUNY Downstate Medical Center- Site Number : 8400039
Brooklyn, New York, 11203, United States
Child Health Care Associates - East Syracuse- Site Number : 8400005
East Syracuse, New York, 13057, United States
GRO Clinical- Site Number : 8400109
Hyde Park, New York, 12538, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400115
Syracuse, New York, 13210, United States
PAS Research-Bronx- Site Number : 8400104
The Bronx, New York, 10460, United States
Advantage Clinical Trials- Site Number : 8400030
The Bronx, New York, 10468, United States
Atrium Health - Myers Park- Site Number : 8400080
Charlotte, North Carolina, 28207, United States
Atrium Health - STRIVE Vaccine Research Clinic- Site Number : 8400060
Charlotte, North Carolina, 28207, United States
Haywood Pediatric and Adolescent Medicine Group- Site Number : 8400051
Clyde, North Carolina, 28721, United States
East Carolina University- Site Number : 8400061
Greenville, North Carolina, 27858, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400077
Statesville, North Carolina, 28625, United States
Legacy Clinical Trials Oklahoma City- Site Number : 8400097
Oklahoma City, Oklahoma, 73103, United States
Cyn3rgy Research- Site Number : 8400029
Gresham, Oregon, 97030, United States
Kid's Way Pediatrics- Site Number : 8400119
Hermitage, Pennsylvania, 16148, United States
Pas Research - Pittsburgh- Site Number : 8400050
Pittsburgh, Pennsylvania, 15227, United States
Neighbors Pediatrics- Site Number : 8400068
Charleston, South Carolina, 29407, United States
Tribe Clinical Research - Simpsonville- Site Number : 8400069
Simpsonville, South Carolina, 29680, United States
Parkside Pediatrics - Simpsonville- Site Number : 8400078
Simpsonville, South Carolina, 29681, United States
Tribe Clinical Research - Spartanburg- Site Number : 8400083
Spartanburg, South Carolina, 29301, United States
Austin Regional Clinic - ARC Four Points- Site Number : 8400082
Austin, Texas, 78726, United States
Cedar Health Research - Dallas- Site Number : 8400092
Dallas, Texas, 75251, United States
PAS Research - Children's Care Clinic- Site Number : 8400012
Edinburg, Texas, 78539, United States
The University of Texas Health Science Center- Site Number : 8400024
Houston, Texas, 77030, United States
Biopharma Informatic - Houston - Business Center Drive- Site Number : 8400108
Houston, Texas, 77043, United States
Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400049
Houston, Texas, 77070, United States
Pediatric Associates - Houston- Site Number : 8400101
Houston, Texas, 77087, United States
Pioneer Research Solutions - Houston - Stancliff Road- Site Number : 8400126
Houston, Texas, 77099, United States
GLRI - McAllen Research- Site Number : 8400098
Pharr, Texas, 78577, United States
AIM Trials- Site Number : 8400052
Plano, Texas, 75093, United States
Pediatric Center - Richmond- Site Number : 8400122
Richmond, Texas, 77469, United States
North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400018
Tomball, Texas, 77375, United States
Wee Care Pediatrics - Kaysville- Site Number : 8400028
Kaysville, Utah, 84037, United States
Wee Care Pediatrics - Layton- Site Number : 8400044
Layton, Utah, 84041, United States
Rio Clinical Trials - Canyon View- Site Number : 8400132
Ogden, Utah, 84404, United States
Utah Valley Pediatrics - Orem- Site Number : 8400053
Orem, Utah, 84057, United States
Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032
Pleasant View, Utah, 84404, United States
Pediatric Care - Provo- Site Number : 8400041
Provo, Utah, 84604, United States
Wee Care Pediatrics - Roy- Site Number : 8400070
Roy, Utah, 84067, United States
J. Lewis Research - Foothill Family Clinic - Salt Lake City- Site Number : 8400058
Salt Lake City, Utah, 84109, United States
Wee Care Pediatrics - Syracuse- Site Number : 8400066
Syracuse, Utah, 84075, United States
National Clinical Research- Site Number : 8400010
Richmond, Virginia, 23294, United States
Full Circle Family Medicine- Site Number : 8400110
Germantown, Wisconsin, 53022, United States
Investigational Site Number : 3400001
San Pedro Sula, 21104, Honduras
Investigational Site Number : 3400002
Tegucigalpa, 11101, Honduras
Investigational Site Number : 3400003
Tegucigalpa, 11101, Honduras
Investigational Site Number : 4840003
León, Guanajuato, 37320, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, 04530, Mexico
Investigational Site Number : 4840007
Morelia, Michoacán, 58350, Mexico
Investigational Site Number : 4840009
Cuernavaca, Morelos, 62290, Mexico
Investigational Site Number : 4840002
Temixco, Morelos, 62587, Mexico
Investigational Site Number : 4840008
Ecatepec de Morelos, 55075, Mexico
Investigational Site Number : 6300001
Bayamón, 00961, Puerto Rico
Investigational Site Number : 6300002
Bayamón, 00961, Puerto Rico
Investigational Site Number : 6300005
Guayama, 00786, Puerto Rico
Investigational Site Number : 6300008
Ponce, 00716, Puerto Rico
Investigational Site Number : 6300004
Ponce, 00717, Puerto Rico
Investigational Site Number : 6300003
San Juan, 00907, Puerto Rico
Investigational Site Number : 6300006
San Juan, 00918, Puerto Rico
Investigational Site Number : 6300007
Trujillo Alto, 00976, Puerto Rico
Investigational Site Number : 7640002
Bangkok, 10400, Thailand
Investigational Site Number : 7640001
Chiang Mai, 50180, Thailand
Investigational Site Number : 7640003
Hat Yai, 90110, Thailand
Investigational Site Number : 7920004
Ankara, 06230, Turkey (Türkiye)
Investigational Site Number : 7920002
Ankara, 06620, Turkey (Türkiye)
Investigational Site Number : 7920006
Ankara, 06800, Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number : 7920007
Istanbul, 34384, Turkey (Türkiye)
Investigational Site Number : 7920009
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number : 7920005
Izmir, 35120, Turkey (Türkiye)
Investigational Site Number : 7920008
Izmir, 35540, Turkey (Türkiye)
Investigational Site Number : 7920010
Trabzon, 61080, Turkey (Türkiye)
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 18, 2025
Primary Completion (Estimated)
October 22, 2027
Study Completion (Estimated)
October 22, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
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