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experimental vaccine

Phase 3

Epidemic Meningitis | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Apr 1, 2026

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_CONTROLLEDBiomarker
Total Trials4
Total Enrollment3,620
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07505810Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 MonthsPHASE3 NOT YET_RECRUITING 880Mar 22, 2026Jan 1, 2028Apr 1, 2026 -
NCT07505823Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 MonthsPHASE3 NOT YET_RECRUITING 1,040Mar 22, 2026Jan 1, 2028Apr 1, 2026 -
NCT07505836Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 MonthsPHASE3 NOT YET_RECRUITING 1,040Mar 22, 2026Jan 1, 2027Apr 1, 2026 -
NCT07505888Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 YearsPHASE3 NOT YET_RECRUITING 660Mar 22, 2026Nov 1, 2026Apr 1, 2026 -
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Study Endpoints
Primary Endpoints
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
Day 30 after three-dose vaccination

seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)

GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
Day 30 after three-dose vaccination

GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)

Secondary Endpoints
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Day 30 after three-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
Day 30 after three-dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Day 30 after three-dose vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
experimental groupEXPERIMENTAL -
active comparator groupACTIVE_COMPARATOR -
Interventions
NameTypeDescription
experimental vaccineBIOLOGICALGroup ACYW135 Meningococcal Conjugate Vaccine
Active Comparator vaccineBIOLOGICALGroup ACYW135 Meningococcal Conjugate Vaccine (CRM197)
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Eligibility Criteria
Age Range3 Months — 5 Months
SexALL
Healthy VolunteersYes

Inclusion Criteria: 1. Healthy participants aged 3 to 5 months. 2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form. 3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures. 4. Pr...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07505810primaryCompletionDate: changed
LOWMay 26, 2026NCT07505836primaryCompletionDate: changed
LOWMay 26, 2026NCT07505888primaryCompletionDate: changed
LOWMay 26, 2026NCT07505823primaryCompletionDate: changed
LOWMay 24, 2026NCT07505810studyFirstPostDate: changed
LOWMay 24, 2026NCT07505888studyFirstPostDate: changed
LOWMay 24, 2026NCT07505823studyFirstPostDate: changed
LOWMay 24, 2026NCT07505836studyFirstPostDate: changed