Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

April 9, 2026 updated by: Sanofi

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
      • San Pedro Sula, Honduras, 21104
        • Investigational Site Number : 3400001
      • Tegucigalpa, Honduras, 11101
        • Investigational Site Number : 3400003
      • Tegucigalpa, Honduras, 11101
        • Investigational Site Number : 3400002
  • Mexico
      • Ecatepec de Morelos, Mexico, 55075
        • Investigational Site Number : 4840008
    • Guanajuato
      • León, Guanajuato, Mexico, 37320
        • Investigational Site Number : 4840003
    • Mexico City
      • Mexico City, Mexico City, Mexico, 04530
        • Investigational Site Number : 4840001
    • Michoacán
      • Morelia, Michoacán, Mexico, 58350
        • Investigational Site Number : 4840007
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Investigational Site Number : 4840009
      • Temixco, Morelos, Mexico, 62587
        • Investigational Site Number : 4840002
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • Investigational Site Number : 6300002
      • Bayamón, Puerto Rico, 00961
        • Investigational Site Number : 6300001
      • Guayama, Puerto Rico, 00786
        • Investigational Site Number : 6300005
      • Ponce, Puerto Rico, 00716
        • Investigational Site Number : 6300008
      • Ponce, Puerto Rico, 00717
        • Investigational Site Number : 6300004
      • San Juan, Puerto Rico, 00907
        • Investigational Site Number : 6300003
      • San Juan, Puerto Rico, 00918
        • Investigational Site Number : 6300006
      • Trujillo Alto, Puerto Rico, 00976
        • Investigational Site Number : 6300007
  • Thailand
      • Bangkok, Thailand, 10400
        • Investigational Site Number : 7640002
      • Chiang Mai, Thailand, 50180
        • Investigational Site Number : 7640001
      • Hat Yai, Thailand, 90110
        • Investigational Site Number : 7640003
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Investigational Site Number : 7920004
      • Ankara, Turkey (Türkiye), 06620
        • Investigational Site Number : 7920002
      • Ankara, Turkey (Türkiye), 06800
        • Investigational Site Number : 7920006
      • Istanbul, Turkey (Türkiye), 34098
        • Investigational Site Number : 7920003
      • Istanbul, Turkey (Türkiye), 34384
        • Investigational Site Number : 7920007
      • Izmir, Turkey (Türkiye), 35100
        • Investigational Site Number : 7920009
      • Izmir, Turkey (Türkiye), 35120
        • Investigational Site Number : 7920005
      • Izmir, Turkey (Türkiye), 35540
        • Investigational Site Number : 7920008
      • Trabzon, Turkey (Türkiye), 61080
        • Investigational Site Number : 7920010
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham- Site Number : 8400130
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research- Site Number : 8400054
      • Oneonta, Alabama, United States, 35121
        • Midway Medical Clinic- Site Number : 8400091
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research- Site Number : 8400121
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic- Site Number : 8400079
      • Sherwood, Arkansas, United States, 72120
        • Helios CR, Inc. - Little Rock- Site Number : 8400090
    • California
      • Fullerton, California, United States, 92831
        • Helping Hands Healthcare Group - Fullerton- Site Number : 8400063
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine- Site Number : 8400055
      • Huntington Park, California, United States, 90255
        • Century Research Institute- Site Number : 8400118
      • Huntington Park, California, United States, 90255
        • Matrix Clinical Research - Huntington Park- Site Number : 8400117
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research - Los Angeles- Site Number : 8400026
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research - Los Angeles- Site Number : 8400123
      • Lynwood, California, United States, 90262
        • Alliance Research Institute - Lynwood- Site Number : 8400099
      • Madera, California, United States, 93637
        • Madera Family Medical Group- Site Number : 8400011
      • Merced, California, United States, 95340
        • FOMAT-Golden Valley Health Centers- Site Number : 8400084
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072
      • Paramount, California, United States, 90723
        • Center for Clinical Trials - Paramount- Site Number : 8400100
      • Sherman Oaks, California, United States, 91356-4173
        • Integrated Clinical Research LLC- Site Number : 8400027
      • West Covina, California, United States, 91790
        • Emanate Health - Queen of the Valley Hospital- Site Number : 8400105
      • Whittier, California, United States, 90601
        • All In One Clinic- Site Number : 8400127
      • Winnetka, California, United States, 91306
        • Amicis Research Center-Winnetka- Site Number : 8400128
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102
    • Florida
      • Doral, Florida, United States, 33122
        • D&H Doral Research Center- Site Number : 8400095
      • Doral, Florida, United States, 33172
        • Dolphin Medical Research, LLC- Site Number : 8400120
      • Doral, Florida, United States, 33172
        • Nextlevel Research Center- Site Number : 8400065
      • Kendall, Florida, United States, 33176
        • CuraCare- Site Number : 8400125
      • Lutz, Florida, United States, 33549
        • PAS RESEARCH-Lutz- Site Number : 8400103
      • Miami, Florida, United States, 33176
        • Abba Medical Research- Site Number : 8400064
      • North Miami, Florida, United States, 33169
        • D&H National Research Center- Site Number : 8400085
      • Pembroke Pines, Florida, United States, 33029
        • Alfa Medical Research LLC- Site Number : 8400111
      • Tampa, Florida, United States, 33613
        • PAS Research - Tampa- Site Number : 8400113
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine - Atlanta- Site Number : 8400093
      • Savannah, Georgia, United States, 31405
        • CenExel - iResearch - Savannah- Site Number : 8400057
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital - Blackfoot- Site Number : 8400114
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials - Blackfoot- Site Number : 8400017
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime- Site Number : 8400022
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Eagle Clinical Research- Site Number : 8400087
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center- Site Number : 8400062
      • Moline, Illinois, United States, 61265
        • MidValley Research - Moline- Site Number : 8400096
    • Indiana
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic - Main Campus- Site Number : 8400023
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services- Site Number : 8400059
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Research- Site Number : 8400014
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center- Site Number : 8400034
      • Louisville, Kentucky, United States, 40202
        • Novak Center For Children's Health- Site Number : 8400073
      • Louisville, Kentucky, United States, 40243
        • Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research - Lafayette- Site Number : 8400046
      • New Orleans, Louisiana, United States, 70125
        • NOLA Research Works- Site Number : 8400035
    • Maryland
      • Columbia, Maryland, United States, 21045
        • The Pediatric Center- Site Number : 8400075
      • Frederick, Maryland, United States, 21702
        • The Pediatric Center of Frederick- Site Number : 8400074
      • Silver Spring, Maryland, United States, 20910
        • Virgo Carter Pediatrics- Site Number : 8400001
    • Michigan
      • Allen Park, Michigan, United States, 48101
        • Michigan Institute of Research- Site Number : 8400131
      • Dearborn, Michigan, United States, 48124
        • Vida Clinical Studies - Dearborn- Site Number : 8400094
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute - Minneapolis- Site Number : 8400002
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group- Site Number : 8400129
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute- Site Number : 8400016
      • Lincoln, Nebraska, United States, 68516
        • Be Well Clinical Studies - Lincoln- Site Number : 8400031
      • Lincoln, Nebraska, United States, 68516
        • Midwest Childrens Health Research Institute- Site Number : 8400021
      • Lincoln, Nebraska, United States, 68522
        • Midwest Children's Health Research Institute - Lincoln - West A Street- Site Number : 8400045
    • Nevada
      • Henderson, Nevada, United States, 89014
        • PAS Research - Henderson- Site Number : 8400033
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center- Site Number : 8400039
      • East Syracuse, New York, United States, 13057
        • Child Health Care Associates - East Syracuse- Site Number : 8400005
      • Hyde Park, New York, United States, 12538
        • GRO Clinical- Site Number : 8400109
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University - Syracuse- Site Number : 8400115
      • The Bronx, New York, United States, 10460
        • PAS Research-Bronx- Site Number : 8400104
      • The Bronx, New York, United States, 10468
        • Advantage Clinical Trials- Site Number : 8400030
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Atrium Health - Myers Park- Site Number : 8400080
      • Charlotte, North Carolina, United States, 28207
        • Atrium Health - STRIVE Vaccine Research Clinic- Site Number : 8400060
      • Clyde, North Carolina, United States, 28721
        • Haywood Pediatric and Adolescent Medicine Group- Site Number : 8400051
      • Greenville, North Carolina, United States, 27858
        • East Carolina University- Site Number : 8400061
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare - Family Medicine- Site Number : 8400077
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Legacy Clinical Trials Oklahoma City- Site Number : 8400097
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research- Site Number : 8400029
    • Pennsylvania
      • Hermitage, Pennsylvania, United States, 16148
        • Kid's Way Pediatrics- Site Number : 8400119
      • Pittsburgh, Pennsylvania, United States, 15227
        • Pas Research - Pittsburgh- Site Number : 8400050
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Neighbors Pediatrics- Site Number : 8400068
      • Simpsonville, South Carolina, United States, 29680
        • Tribe Clinical Research - Simpsonville- Site Number : 8400069
      • Simpsonville, South Carolina, United States, 29681
        • Parkside Pediatrics - Simpsonville- Site Number : 8400078
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research - Spartanburg- Site Number : 8400083
    • Texas
      • Austin, Texas, United States, 78726
        • Austin Regional Clinic - ARC Four Points- Site Number : 8400082
      • Dallas, Texas, United States, 75251
        • Cedar Health Research - Dallas- Site Number : 8400092
      • Edinburg, Texas, United States, 78539
        • PAS Research - Children's Care Clinic- Site Number : 8400012
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center- Site Number : 8400024
      • Houston, Texas, United States, 77043
        • Biopharma Informatic - Houston - Business Center Drive- Site Number : 8400108
      • Houston, Texas, United States, 77070
        • Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400049
      • Houston, Texas, United States, 77087
        • Pediatric Associates - Houston- Site Number : 8400101
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions - Houston - Stancliff Road- Site Number : 8400126
      • Pharr, Texas, United States, 78577
        • GLRI - McAllen Research- Site Number : 8400098
      • Plano, Texas, United States, 75093
        • AIM Trials- Site Number : 8400052
      • Richmond, Texas, United States, 77469
        • Pediatric Center - Richmond- Site Number : 8400122
      • Tomball, Texas, United States, 77375
        • North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400018
    • Utah
      • Kaysville, Utah, United States, 84037
        • Wee Care Pediatrics - Kaysville- Site Number : 8400028
      • Layton, Utah, United States, 84041
        • Wee Care Pediatrics - Layton- Site Number : 8400044
      • Ogden, Utah, United States, 84404
        • Rio Clinical Trials - Canyon View- Site Number : 8400132
      • Orem, Utah, United States, 84057
        • Utah Valley Pediatrics - Orem- Site Number : 8400053
      • Pleasant View, Utah, United States, 84404
        • Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032
      • Provo, Utah, United States, 84604
        • Pediatric Care - Provo- Site Number : 8400041
      • Roy, Utah, United States, 84067
        • Wee Care Pediatrics - Roy- Site Number : 8400070
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research - Foothill Family Clinic - Salt Lake City- Site Number : 8400058
      • Syracuse, Utah, United States, 84075
        • Wee Care Pediatrics - Syracuse- Site Number : 8400066
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research- Site Number : 8400010
    • Wisconsin
      • Germantown, Wisconsin, United States, 53022
        • Full Circle Family Medicine- Site Number : 8400110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 42 to 89 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

Exclusion Criteria:

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
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: PCV21
Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA
Biological: PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • 515
Biological: M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Other Names:
  • M-M-R™ II
Biological: RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Other Names:
  • RotaTeq™
Biological: Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Vaxelis™
Biological: Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Other Names:
  • Varivax™
Biological: Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
Other Names:
  • Rotarix™
Biological: Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
Other Names:
  • Priorix™
Biological: VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Other Names:
  • VAQTA™
Biological: Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Other Names:
  • Havrix™
Active Comparator: Group 2: 20vPCV
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA
Biological: M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Other Names:
  • M-M-R™ II
Biological: RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Other Names:
  • RotaTeq™
Biological: Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Vaxelis™
Biological: Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Other Names:
  • Varivax™
Biological: Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Prevnar20™
Biological: Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
Other Names:
  • Rotarix™
Biological: Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
Other Names:
  • Priorix™
Biological: VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Other Names:
  • VAQTA™
Biological: Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Other Names:
  • Havrix™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Time Frame: 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
Time Frame: 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 any immediate adverse events (AEs)
Time Frame: Within 30 minutes after each vaccination
Number of participants experiencing solicited and unsolicited immediate AEs
Within 30 minutes after each vaccination
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
Time Frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
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)
Time Frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing AESIs
Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

October 22, 2027

Study Completion (Estimated)

October 22, 2027

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSK05
  • U1111-1295-5983 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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