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Group ACYW135X Meningococcal Conjugate Vaccine

Phase 1

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Jan 28, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as high-dose Group ACYW135X Meningococcal Conjugate Vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Group ACYW135X Meningococcal Conjugate Vaccine · 1 trial · 1 indication

Phase 1 1
NCT07374510Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate VaccineMeningococcal Meningitis
NOT YET_RECRUITING150 Analytics
PHASE1NOT YET_RECRUITING
Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine
Meningococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)
30 days

The incidence rates of adverse reactions 30 days after vaccination

Secondary Endpoints

Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
30 days
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
high-dose experimental groupEXPERIMENTAL2\~59 years old
medium-dose experimental groupEXPERIMENTAL2\~59 years old
low-dose experimental groupEXPERIMENTAL2\~6 years old
placebo groupPLACEBO_COMPARATOR2\~6 years old
active control groupACTIVE_COMPARATOR2\~3 years old

Interventions

NameTypeDescription
high-dose Group ACYW135X Meningococcal Conjugate VaccineBIOLOGICALhigh-dose Group ACYW135X Meningococcal Conjugate Vaccine
medium-dose Group ACYW135X Meningococcal Conjugate VaccineBIOLOGICALmedium-dose Group ACYW135X Meningococcal Conjugate Vaccine
low-dose Group ACYW135X Meningococcal Conjugate VaccineBIOLOGICALlow-dose Group ACYW135X Meningococcal Conjugate Vaccine
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)BIOLOGICALGroup ACYW135 Meningococcal Conjugate Vaccine (CRM197)
PlaceboBIOLOGICALplacebo
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Eligibility Criteria

Age Range2 Years to 59 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy participants aged 2 to 59 years; * The participant and/or their legal guardian can understand and voluntarily sign the informed consent form (for participants aged 8 to 17 years, the form must be signed jointly by the participant and their legal guardian); * Be willing...

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