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PCV21

Phase 3

Sickle Cell Disease | Monoclonal antibody | Hematology |Sanofi|Last Updated: Apr 15, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical trial landscape

PCV21 · 2 trials · 2 indications

Phase 3 2
NCT07247188Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell DiseaseSickle Cell Disease
RECRUITING100 Analytics
NCT06838000Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and AdolescentsPneumococcal Infections
ACTIVE NOT_RECRUITING1,268 Analytics
PHASE3RECRUITING
Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Sickle Cell Disease
NCT07247188100
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PHASE3ACTIVE NOT_RECRUITING
Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
Pneumococcal Infections
NCT068380001,268
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Study Endpoints
Primary Endpoints
Number of participants reporting immediate adverse events (AEs)
Within 30 minutes post-vaccination

Unsolicited (spontaneously reported) systemic AEs after injection of a pneumococcal vaccine

Number of participants reporting solicited injection site and solicited systemic reactions
Up to Day 7 post-vaccination
Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after injection of a pneumococcal vaccine
Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
From day 0 to day 181

SAEs and AESIs are collected throughout the study period

Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21
On day 30 post-vaccination

Ab (antibody) concentrations for each pneumococcal serotype measured by electro-chemiluminescence (ECL) assay

Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine
Within 30 days after vaccination
Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific IgG concentrations for all serotypes included in PCV21
On day 30 after last vaccination

Ab (antibody) concentrations for each pneumococcal serotype are measured.

Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21
On day 30

Serotype specific OPA titers for each pneumococcal serotype are determined.

Number of Children (2-5 years of age [YoA]):with serotype specific IgG concentrations for all serotypes included in PCV21
On day 30

Ab concentrations for each pneumococcal serotype are measured.

Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21
On day 30

Serotype specific OPA titers for each pneumococcal serotype are determined.

Secondary Endpoints
Number of participants with serotype-specific IgG concentrations for all serotypes included in PCV21
Pre-vaccination and at 30 days post-vaccination
Number of participants with serotype specific opsonophagocytic activity (OPA) titers for all serotypes included in PCV21
On day 30
Number of Children/adolescents (≥ 2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21
On day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Investigated Vaccine: PCV21EXPERIMENTALParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Comparator Vaccine: 20vPCVACTIVE_COMPARATORParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Infants (7 to 11 MoA)EXPERIMENTALParticipants will receive 3 intramuscular injections of pneumococcal vaccine with an interval of: * 4 to 8 weeks (28 to 56 days) between the 1st dose and the 2nd dose * 8 to 12 weeks (56 to 84 days) between the 2nd dose and the 3rd dose AND age ≥ 12 MoA at 3rd dose
Toddlers (12 to 23 MoA)EXPERIMENTALParticipants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses
Children/adolescent (2 to 5 and 6 to 17 YoA)EXPERIMENTALParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Interventions
NameTypeDescription
PCV21BIOLOGICALInvestigational pneumococcal conjugate vaccine
20vPCVBIOLOGICAL20-valent pneumococcal conjugate vaccine
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Eligibility Criteria
Age Range2 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: AGE * Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS * Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS * A pa...

Countries:United StatesDominican RepublicEstoniaPolandThailand
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Competitive Landscape -Sickle Cell Disease 27 trials
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Etavopivat Low dose
Novartis AG Sponsored ADRNVS4PHASE3Crizanlizumab
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Vertex Pharmaceuticals IncorporatedVRTX3PHASE3CTX001
Agios Pharmaceuticals, Inc.AGIO2PHASE2Mitapivat
Pfizer Inc.PFE1PHASE2Osivelotor
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986470, Famotidine, Pantoprazole
Fulcrum Therapeutics, Inc.FULC1PHASE2Pociredir
Beam Therapeutics, Inc.BEAM2PHASE1BEAM-101
Editas Medicine, Inc.EDIT2PHASE1EDIT-301
Disc Medicine, Inc.IRON1PHASE1DISC-3405
Illumina, Inc.ILMN1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07247188primaryCompletionDate: changed
LOWMay 26, 2026NCT06838000primaryCompletionDate: changed
LOWMay 24, 2026NCT07247188studyFirstPostDate: changed
LOWMay 24, 2026NCT06838000studyFirstPostDate: changed