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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06736041
Registration number
NCT06736041
Ethics application status
Date submitted
11/12/2024
Date registered
16/12/2024
Date last updated
21/08/2025
Titles & IDs
Public title
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
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Scientific title
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
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Secondary ID [1]
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U1111-1294-7860
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Secondary ID [2]
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PSK03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Immunization
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - PCV21 vaccine
Treatment: Other - Prevnar 20 vaccine
Treatment: Other - M-M-R II vaccine
Treatment: Other - RotaTeq
Treatment: Other - Vaxelis vaccine
Treatment: Other - Varivax
Treatment: Other - Hexaxim Vaccine
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.
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.
Treatment: Other: PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Treatment: Other: Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Treatment: Other: M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Treatment: Other: RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Treatment: Other: Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Treatment: Other: Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Treatment: Other: Hexaxim Vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Seroresponse rate for PCV21 serotypes
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Assessment method [1]
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Serotype specific IgG concentration = 0.35 µg/mL
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Timepoint [1]
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30 days post-dose 3
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Primary outcome [2]
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IgG concentration for PCV21 serotypes
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Assessment method [2]
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Serotype specific IgG Geometric Mean Concentration (GMC)
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Timepoint [2]
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30 days post-dose 3
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Primary outcome [3]
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IgG concentration for PCV21 serotypes
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Assessment method [3]
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Serotype specific IgG GMC post-dose 4
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Timepoint [3]
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30 days post-dose 4
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Secondary outcome [1]
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Anti- hepatitis B surface antigen (HBsAg) Ab
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Assessment method [1]
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% Antibody concentrations = 10 milli international units per milliliter (mIU/mL)
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Timepoint [1]
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30 days post-dose 3
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Secondary outcome [2]
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Anti- polyribosylribitol phosphate (PRP) Ab
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Assessment method [2]
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% Antibody concentrations = 0.15 micrograms per milliliter (µg/mL)
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Timepoint [2]
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30 days post-dose 3
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Secondary outcome [3]
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Anti-poliovirus types (1, 2, and 3) Ab
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Assessment method [3]
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% Antibody titers = 1:8
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Timepoint [3]
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30 days post-dose 3
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Secondary outcome [4]
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Anti-diphtheria Ab concentrations
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Assessment method [4]
0
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% Antibody concentrations = 0.1 IU/mL
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Timepoint [4]
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30 days post-dose 3
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Secondary outcome [5]
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Anti-tetanus Ab concentrations
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Assessment method [5]
0
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% Antibody concentrations = 0.1 IU/mL
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Timepoint [5]
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30 days post-dose 3
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Secondary outcome [6]
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Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
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Assessment method [6]
0
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Antibody GMC
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Timepoint [6]
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30 days post-dose 3
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Secondary outcome [7]
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Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations
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Assessment method [7]
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Antibody GMC
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Timepoint [7]
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30 days post-dose 3
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Secondary outcome [8]
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Anti-measles Ab concentrations
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Assessment method [8]
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% Antibody concentrations = 225 milli international units per milliliter (mIU/mL)
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Timepoint [8]
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30 days post-dose 4
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Secondary outcome [9]
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Anti-measles Ab concentrations
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Assessment method [9]
0
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Antibody GMC
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Timepoint [9]
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30 days post-dose 4
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Secondary outcome [10]
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Anti-mumps Ab concentrations
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Assessment method [10]
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% Anti-mumps Ab concentrations = 10 Ab units (AbU)/mL
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Timepoint [10]
0
0
30 days post-dose 4
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Secondary outcome [11]
0
0
Anti-mumps Ab concentrations
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Assessment method [11]
0
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Antibody GMC
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Timepoint [11]
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30 days post-dose 4
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Secondary outcome [12]
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Anti-rubella Ab concentrations
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Assessment method [12]
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% Anti-rubella Ab concentrations = 10 IU/mL
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Timepoint [12]
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30 days post-dose 4
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Secondary outcome [13]
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Anti-rubella Ab concentrations
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Assessment method [13]
0
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Antibody GMC
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Timepoint [13]
0
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30 days post-dose 4
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Secondary outcome [14]
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Anti-varicella Ab concentrations
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Assessment method [14]
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Anti-varicella Ab concentrations = 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL
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Timepoint [14]
0
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30 days post-dose 4
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Secondary outcome [15]
0
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IgG concentration for the additional serotype 9N
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Assessment method [15]
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Serotype 9N specific IgG concentration = 0.35 µg/mL
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Timepoint [15]
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30 days post-dose 3
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Secondary outcome [16]
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IgG concentration for serotype 3
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Assessment method [16]
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Serotype 3 specific IgG concentration = 0.35 µg/mL
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Timepoint [16]
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30 days post-dose 3
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Secondary outcome [17]
0
0
IgG concentration for additional serotype 9N
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Assessment method [17]
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0
Serotype 9N specific IgG GMC
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Timepoint [17]
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30 days post-dose 3
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Secondary outcome [18]
0
0
IgG concentration for serotype 3
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Assessment method [18]
0
0
Serotype 3 specific IgG GMC
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Timepoint [18]
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30 days post-dose 3
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Secondary outcome [19]
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Serotype 9N specific IgG GMC post-dose 4
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Assessment method [19]
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Serotype 9N specific IgG GMC post-dose 4
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Timepoint [19]
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30 days post-dose 4
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Secondary outcome [20]
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IgG concentration for additional serotype 9N
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Assessment method [20]
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Serotype 9N specific IgG GMC post-dose 4
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Timepoint [20]
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30 days post-dose 4
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Secondary outcome [21]
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IgG concentration for serotype 3
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Assessment method [21]
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Serotype 3 specific IgG GMC post-dose 4
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Timepoint [21]
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30 days post-dose 4
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Secondary outcome [22]
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Seroresponse rate for PCV21 serotypes
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Assessment method [22]
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Serotype specific IgG concentration = 0.35 µg/mL
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Timepoint [22]
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30 days post-dose 4
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Secondary outcome [23]
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IgG concentration for PCV21 serotypes
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Assessment method [23]
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Serotype specific IgG GMC prior to and post-dose 4
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Timepoint [23]
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Before dose 4 and 30 days post-dose 4
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Secondary outcome [24]
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Serotype specific OPA titers for all serotypes included in PCV21
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Assessment method [24]
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Antibody GMC
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Timepoint [24]
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30 days post-dose 3
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Secondary outcome [25]
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Serotype specific OPA titers = lower limit of quantitation (LLOQ) for all serotypes included in PCV21
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Assessment method [25]
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Antibody GMC
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Timepoint [25]
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30 days post-dose 3
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Secondary outcome [26]
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Serotype specific OPA titers for all serotypes included in PCV21
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Assessment method [26]
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Antibody GMC prior to and post-dose 4
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Timepoint [26]
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Before dose 4 and 30 days post-dose 4
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Secondary outcome [27]
0
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Serotype specific OPA titers = lower limit of quantitation (LLOQ) for all serotypes included in PCV21
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Assessment method [27]
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Antibody GMC prior to and post-dose 4
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Timepoint [27]
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Before dose 4 and 30 days post-dose 4
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Secondary outcome [28]
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Presence of any immediate adverse events (AEs)
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Assessment method [28]
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Number of participants experiencing solicited and unsolicited immediate AEs
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Timepoint [28]
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Within 30 minutes after each vaccine injection
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Secondary outcome [29]
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Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
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Assessment method [29]
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Number of participants experiencing solicited injection site and systemic reactions
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Timepoint [29]
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Through 7 days after each vaccine injection
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Secondary outcome [30]
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Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
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Assessment method [30]
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Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
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Timepoint [30]
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Through 30 days after each vaccine injection
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Secondary outcome [31]
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Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
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Assessment method [31]
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Number of participants experiencing SAEs
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Timepoint [31]
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Throughout the study (through 6 months post-last vaccine injection), approximately 20 months
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Eligibility
Key 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
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Minimum age
42
Days
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Maximum age
89
Days
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/05/2027
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Actual
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Sample size
Target
1630
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Investigational Site Number : 0360001 - Westmead
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Recruitment hospital [2]
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Investigational Site Number : 0360004 - Brisbane
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Recruitment hospital [3]
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Investigational Site Number : 0360005 - Southport
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Recruitment hospital [4]
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Investigational Site Number : 0360002 - Parkville
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Recruitment hospital [5]
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Investigational Site Number : 0360003 - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4101 - Brisbane
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
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0
California
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Country [4]
0
0
United States of America
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State/province [4]
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0
District of Columbia
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Country [5]
0
0
United States of America
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State/province [5]
0
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Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
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Idaho
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Country [7]
0
0
United States of America
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State/province [7]
0
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Kansas
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Country [8]
0
0
United States of America
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State/province [8]
0
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Ohio
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
0
0
South Carolina
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Utah
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Country [13]
0
0
France
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State/province [13]
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Marseille
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Country [14]
0
0
Honduras
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State/province [14]
0
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Tegucigalpa
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Country [15]
0
0
Netherlands
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State/province [15]
0
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Florida
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Country [16]
0
0
Norway
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State/province [16]
0
0
Texas
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Country [17]
0
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Poland
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State/province [17]
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Kuyavian-Pomeranian Voivodeship
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Country [18]
0
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Poland
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State/province [18]
0
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Michigan
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Country [19]
0
0
Puerto Rico
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State/province [19]
0
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Caguas
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Country [20]
0
0
Puerto Rico
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State/province [20]
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Ponce
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Country [21]
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Puerto Rico
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State/province [21]
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San Juan
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Country [22]
0
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Puerto Rico
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State/province [22]
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Trujillo Alto
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Country [23]
0
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South Korea
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State/province [23]
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Busan
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Country [24]
0
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South Korea
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State/province [24]
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Daegu
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Country [25]
0
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South Korea
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State/province [25]
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Gwangju
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Country [26]
0
0
South Korea
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State/province [26]
0
0
Gyeonggi-do
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Country [27]
0
0
South Korea
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State/province [27]
0
0
Gyeongsangnam-do
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Country [28]
0
0
South Korea
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State/province [28]
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Incheon-gwangyeoksi
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Country [29]
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South Korea
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State/province [29]
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Jeollabuk-do
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Country [30]
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South Korea
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State/province [30]
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Seoul-teukbyeolsi
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Country [31]
0
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Thailand
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State/province [31]
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0
Bangkok
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Country [32]
0
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Thailand
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State/province [32]
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Khon Kaen
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Country [33]
0
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Thailand
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State/province [33]
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Pathumwan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi Pasteur, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06736041
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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0
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free for US & Canada)
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Address
0
0
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Country
0
0
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Phone
0
0
800-633-1610
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06736041
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