Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

April 21, 2026 updated by: Sanofi Pasteur, a Sanofi Company

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity 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 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 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.

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)

1714

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Investigational Site Number : 0360001
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Investigational Site Number : 0360004
      • Southport, Queensland, Australia, 4215
        • Investigational Site Number : 0360005
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Investigational Site Number : 0360002
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • Investigational Site Number : 0360003
  • Honduras
      • San Pedro Sula, Honduras
        • Investigational Site Number : 3400001
      • Tegucigalpa, Honduras, 11101
        • Investigational Site Number : 3400003
      • Tegucigalpa, Honduras, 11101
        • Investigational Site Number : 3400002
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Investigational Site Number : 6300004
      • Guayama, Puerto Rico, 00786
        • Investigational Site Number : 6300008
      • Ponce, Puerto Rico, 00716
        • Investigational Site Number : 6300003
      • San Juan, Puerto Rico, 00918
        • Investigational Site Number : 6300002
      • San Juan, Puerto Rico, 00936
        • Investigational Site Number : 6300006
      • Trujillo Alto, Puerto Rico, 00976
        • Investigational Site Number : 6300005
  • South Korea
    • Busan
      • Busan, Busan, South Korea, 49241
        • Investigational Site Number : 4100023
    • Daegu
      • Daegu, Daegu, South Korea, 41944
        • Investigational Site Number : 4100030
      • Daegu, Daegu, South Korea, 42601
        • Investigational Site Number : 4100024
    • Gwangju
      • Gwangju, Gwangju, South Korea, 61453
        • Investigational Site Number : 4100034
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Investigational Site Number : 4100020
      • Anyang-si, Gyeonggi-do, South Korea, 14068
        • Investigational Site Number : 4100002
      • Bucheon-si, Gyeonggi-do, South Korea, 14584
        • Investigational Site Number : 4100013
      • Bucheon-si, Gyeonggi-do, South Korea, 14647
        • Investigational Site Number : 4100029
      • Hwaseong-si, Gyeonggi-do, South Korea, 18450
        • Investigational Site Number : 4100014
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Investigational Site Number : 4100011
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Investigational Site Number : 4100001
    • Gyeongsangnam-do
      • Changwon-Si, Gyeongsangnam-do, South Korea, 51472
        • Investigational Site Number : 4100027
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Investigational Site Number : 4100010
    • Incheon-gwangyeoksi
      • Bupyeong-Gu, Incheon-gwangyeoksi, South Korea, 21431
        • Investigational Site Number : 4100017
      • Incheon, Incheon-gwangyeoksi, South Korea, 21565
        • Investigational Site Number : 4100006
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Investigational Site Number : 4100025
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 06351
        • Investigational Site Number : 4100003
      • Seoul, Seoul-teukbyeolsi, South Korea, 03080
        • Investigational Site Number : 4100004
      • Seoul, Seoul-teukbyeolsi, South Korea, 01812
        • Investigational Site Number : 4100019
      • Seoul, Seoul-teukbyeolsi, South Korea, 01830
        • Investigational Site Number : 4100008
      • Seoul, Seoul-teukbyeolsi, South Korea, 02841
        • Investigational Site Number : 4100005
      • Seoul, Seoul-teukbyeolsi, South Korea, 03312
        • Investigational Site Number : 4100009
      • Seoul, Seoul-teukbyeolsi, South Korea, 03722
        • Investigational Site Number : 4100015
      • Seoul, Seoul-teukbyeolsi, South Korea, 05030
        • Investigational Site Number : 4100007
      • Seoul, Seoul-teukbyeolsi, South Korea, 06273
        • Investigational Site Number : 4100031
      • Seoul, Seoul-teukbyeolsi, South Korea, 06591
        • Investigational Site Number : 4100026
      • Seoul, Seoul-teukbyeolsi, South Korea, 07345
        • Investigational Site Number : 4100022
      • Seoul, Seoul-teukbyeolsi, South Korea, 07985
        • Investigational Site Number : 4100018
      • Seoul, Seoul-teukbyeolsi, South Korea, 08308
        • Investigational Site Number : 4100016
  • Thailand
      • Bangkok, Thailand, 10330
        • Investigational Site Number : 7640007
      • Bangkok, Thailand, 10700
        • Investigational Site Number : 7640005
      • Khon Kaen, Thailand, 40002
        • Investigational Site Number : 7640004
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Sun City Clinical Research- Site Number : 8400247
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research- Site Number : 8400029
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Northwest Arkansas Pediatric Clinic- Site Number : 8400030
    • California
      • Fountain Valley, California, United States, 92708
        • Southland Clinical Research Center- Site Number : 8400243
      • Huntington Park, California, United States, 90255
        • Century Research Institute- Site Number : 8400065
      • Huntington Park, California, United States, 90255
        • Matrix Clinical Research - Huntington Park- Site Number : 8400012
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research - Los Angeles- Site Number : 8400013
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles Medical Center- Site Number : 8400238
      • Pasadena, California, United States, 91101
        • Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259
      • Ventura, California, United States, 93003
        • FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Velocity Clinical Research - Washington DC- Site Number : 8400049
    • Florida
      • Clearwater, Florida, United States, 33756
        • PAS Research- Site Number : 8400123
      • Doral, Florida, United States, 33166
        • Prohealth Research Center- Site Number : 8400159
      • Homestead, Florida, United States, 33030
        • NurtureGen Research- Site Number : 8400205
      • Miami, Florida, United States, 33126
        • EMDA Clinical Research- Site Number : 8400237
      • Miami, Florida, United States, 33135
        • Dade Research Center- Site Number : 8400007
      • Miami, Florida, United States, 33142
        • Acevedo Clinical Research Associates- Site Number : 8400089
      • Miami, Florida, United States, 33155
        • Miami Clinical Research Tower- Site Number : 8400189
      • Miami, Florida, United States, 33183
        • Vasconcello-Cohen MD Research, LLC- Site Number : 8400248
      • Miami, Florida, United States, 33184
        • Bio-Medical Research- Site Number : 8400147
      • Miami, Florida, United States, 33184
        • High Quality Research- Site Number : 8400245
      • Miami Lakes, Florida, United States, 33014
        • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032
      • Miami Lakes, Florida, United States, 33016
        • BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203
      • Orange City, Florida, United States, 32763
        • Optimal Research Sites- Site Number : 8400232
      • Pensacola, Florida, United States, 32501
        • SEC Clinical Research - Pensacola- Site Number : 8400003
      • Tampa, Florida, United States, 33612
        • National Clinical Trials - Tampa- Site Number : 8400229
      • Tampa, Florida, United States, 33613
        • PAS Research - Tampa- Site Number : 8400002
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners - Ammon- Site Number : 8400239
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Women's Healthcare- Site Number : 8400085
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research- Site Number : 8400060
      • Rexburg, Idaho, United States, 83440
        • Clinical Research Prime Rexburg- Site Number : 8400250
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic- Site Number : 8400061
      • Topeka, Kansas, United States, 66604
        • Cotton O'Neil Pediatrics- Site Number : 8400009
    • Maryland
      • Columbia, Maryland, United States, 21045
        • KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242
    • Michigan
      • Allen Park, Michigan, United States, 48101
        • Michigan Institute of Research- Site Number : 8400207
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Hospital- Site Number : 8400244
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Vector Clinical Trials- Site Number : 8400249
    • New Jersey
      • Lindenwold, New Jersey, United States, 08021
        • Hawthorne- Bienstar Lindenwold- Site Number : 8400256
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Health Sciences Center- Site Number : 8400240
    • New York
      • Staten Island, New York, United States, 10309
        • Hawthorne Health - Staten Island- Site Number : 8400254
      • The Bronx, New York, United States, 10456
        • Prime Global Research- Site Number : 8400246
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research - Monroe- Site Number : 8400225
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research- Site Number : 8400087
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74107
        • Oklahoma State University Center for Health Sciences- Site Number : 8400121
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center - North Charleston- Site Number : 8400064
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112
      • Corpus Christi, Texas, United States, 78413
        • South Texas Clinical Research- Site Number : 8400025
      • Dallas, Texas, United States, 75237
        • FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173
      • Fort Worth, Texas, United States, 76104
        • Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072
      • Houston, Texas, United States, 77008
        • Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
      • Houston, Texas, United States, 77029
        • Gonzalez Family & Occupational Medicine- Site Number : 8400035
      • Houston, Texas, United States, 77057
        • Private Practice - Dr. Chinyere N. Awa- Site Number : 8400252
      • Houston, Texas, United States, 77071
        • La Providence Pediatrics & Family Clinics- Site Number : 8400026
      • Houston, Texas, United States, 77090
        • Houston Clinical Research Associates- Site Number : 8400018
      • Katy, Texas, United States, 77450
        • Biopharma Informatic - Katy - Katy Freeway- Site Number : 8400258
      • League City, Texas, United States, 77573
        • Maximos Ob/Gyn- Site Number : 8400056
      • Richmond, Texas, United States, 77469
        • Pediatric Center - Richmond- Site Number : 8400068
      • Rosharon, Texas, United States, 77583
        • LinQ Research, LLC - Rosharon- Site Number : 8400257
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic - Layton Antelope A- Site Number : 8400241
      • Murray, Utah, United States, 84107
        • Wasatch Pedicatrics- Site Number : 8400153
      • Ogden, Utah, United States, 84404
        • Rio Clinical Trials - Canyon View- Site Number : 8400222
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236

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 vaccines being administered in the study
  • History of seizure or significant stable or progressive neurological 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/legally acceptable representative (LAR), 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 vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
  • Previous vaccination against S. pneumoniae
  • Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and 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 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax.
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: Hexaxim Vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Hexaxim®
Active Comparator: Group 2: 20vPCV
Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax.
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: Hexaxim Vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Hexaxim®
Biological: Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Other Names:
  • Prevnar20®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroresponse rate for PCV21 serotypes
Time Frame: 30 days post-dose 3
Serotype specific IgG concentration ≥ 0.35 µg/mL
30 days post-dose 3
IgG concentration for PCV21 serotypes
Time Frame: 30 days post-dose 3
Serotype specific IgG Geometric Mean Concentration (GMC)
30 days post-dose 3
IgG concentration for PCV21 serotypes
Time Frame: 30 days post-dose 4
Serotype specific IgG GMC post-dose 4
30 days post-dose 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti- hepatitis B surface antigen (HBsAg) Ab
Time Frame: 30 days post-dose 3
% Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)
30 days post-dose 3
Anti- polyribosylribitol phosphate (PRP) Ab
Time Frame: 30 days post-dose 3
% Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)
30 days post-dose 3
Anti-poliovirus types (1, 2, and 3) Ab
Time Frame: 30 days post-dose 3
% Antibody titers ≥ 1:8
30 days post-dose 3
Anti-diphtheria Ab concentrations
Time Frame: 30 days post-dose 3
% Antibody concentrations ≥ 0.1 IU/mL
30 days post-dose 3
Anti-tetanus Ab concentrations
Time Frame: 30 days post-dose 3
% Antibody concentrations ≥ 0.1 IU/mL
30 days post-dose 3
Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
Time Frame: 30 days post-dose 3
Antibody GMC
30 days post-dose 3
Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations
Time Frame: 30 days post-dose 3
Antibody GMC
30 days post-dose 3
Anti-measles Ab concentrations
Time Frame: 30 days post-dose 4
% Antibody concentrations ≥ 225 milli international units per milliliter (mIU/mL)
30 days post-dose 4
Anti-measles Ab concentrations
Time Frame: 30 days post-dose 4
Antibody GMC
30 days post-dose 4
Anti-mumps Ab concentrations
Time Frame: 30 days post-dose 4
% Anti-mumps Ab concentrations ≥ 10 Ab units (AbU)/mL
30 days post-dose 4
Anti-mumps Ab concentrations
Time Frame: 30 days post-dose 4
Antibody GMC
30 days post-dose 4
Anti-rubella Ab concentrations
Time Frame: 30 days post-dose 4
% Anti-rubella Ab concentrations ≥ 10 IU/mL
30 days post-dose 4
Anti-rubella Ab concentrations
Time Frame: 30 days post-dose 4
Antibody GMC
30 days post-dose 4
Anti-varicella Ab concentrations
Time Frame: 30 days post-dose 4
Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL
30 days post-dose 4
IgG concentration for the additional serotype 9N
Time Frame: 30 days post-dose 3
Serotype 9N specific IgG concentration ≥ 0.35 µg/mL
30 days post-dose 3
IgG concentration for serotype 3
Time Frame: 30 days post-dose 3
Serotype 3 specific IgG concentration ≥ 0.35 µg/mL
30 days post-dose 3
IgG concentration for additional serotype 9N
Time Frame: 30 days post-dose 3
Serotype 9N specific IgG GMC
30 days post-dose 3
IgG concentration for serotype 3
Time Frame: 30 days post-dose 3
Serotype 3 specific IgG GMC
30 days post-dose 3
Serotype 9N specific IgG GMC post-dose 4
Time Frame: 30 days post-dose 4
Serotype 9N specific IgG GMC post-dose 4
30 days post-dose 4
IgG concentration for additional serotype 9N
Time Frame: 30 days post-dose 4
Serotype 9N specific IgG GMC post-dose 4
30 days post-dose 4
IgG concentration for serotype 3
Time Frame: 30 days post-dose 4
Serotype 3 specific IgG GMC post-dose 4
30 days post-dose 4
Seroresponse rate for PCV21 serotypes
Time Frame: 30 days post-dose 4
Serotype specific IgG concentration ≥ 0.35 µg/mL
30 days post-dose 4
IgG concentration for PCV21 serotypes
Time Frame: Before dose 4 and 30 days post-dose 4
Serotype specific IgG GMC prior to and post-dose 4
Before dose 4 and 30 days post-dose 4
Serotype specific OPA titers for all serotypes included in PCV21
Time Frame: 30 days post-dose 3
Antibody GMC
30 days post-dose 3
Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Time Frame: 30 days post-dose 3
Antibody GMC
30 days post-dose 3
Serotype specific OPA titers for all serotypes included in PCV21
Time Frame: Before dose 4 and 30 days post-dose 4
Antibody GMC prior to and post-dose 4
Before dose 4 and 30 days post-dose 4
Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Time Frame: Before dose 4 and 30 days post-dose 4
Antibody GMC prior to and post-dose 4
Before dose 4 and 30 days post-dose 4
Presence of any immediate adverse events (AEs)
Time Frame: Within 30 minutes after each vaccine injection
Number of participants experiencing solicited and unsolicited immediate AEs
Within 30 minutes after each vaccine injection
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 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 20 months
Number of participants experiencing SAEs
Throughout the study (through 6 months post-last vaccine injection), approximately 20 months

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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.

General Publications

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)

December 18, 2024

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSK03
  • U1111-1294-7860 (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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