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Pneumococcal Vaccine Polyvalent-Pneumovax 23

Phase 2

Pneumococcal Immunization | Monoclonal antibody | Other |Sanofi|Last Updated: Sep 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment750
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04583618Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.PHASE2 COMPLETED 750Oct 8, 2020Jan 20, 2022Sep 8, 202517 United States
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Study Endpoints
Primary Endpoints
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Post-vaccination at Day 31

The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.

Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31

The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.

Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Post-vaccination at Day 31

The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31

The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.

Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Within 30 minutes post-vaccination

An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.

Number of Participants With Solicited Injection Site Reactions
Up to 7 Days post-vaccination (Day 8)

A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.

Number of Participants With Solicited Systemic Reactions
Up to 7 Days post-vaccination (Day 8)

A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.

Number of Participants With Unsolicited AEs
Within 30 days post-vaccination

An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.

Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SP0202-IIbEXPERIMENTALOne dose at Day 1
SP0202-VIEXPERIMENTALOne dose at Day 1
SP0202-VIIEXPERIMENTALOne dose at Day 1
Prevnar 13ACTIVE_COMPARATOROne dose at Day 1
Pneumovax 23ACTIVE_COMPARATOROne dose at Day 1
Interventions
NameTypeDescription
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIbBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VIBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VIIBIOLOGICALPharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal 13 - valent conjugate vaccine-Prevnar 13BIOLOGICALPharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Vaccine Polyvalent-Pneumovax 23BIOLOGICALPharmaceutical form:Solution for injection Route of administration: intramuscular
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Eligibility Criteria
Age Range50 Years — 84 Years
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion criteria : \- Aged 50 to 84 years on the day of inclusion . Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks a...

Countries:United States
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