MCV4 (Epidemic Meningitis Vaccine) — Pipeline & Regulatory Status

Category Resource

Explore licensed vaccines, adverse event reporting data, and history for this disease.

View Epidemic Meningitis Vaccine Guide →

Development Phase Phase 3 Clinical Trial Primary Status

Platform Technology Biological (unspecified platform) Biologic Architecture

Target Indication Epidemic Meningitis Pathogen / Antigen

Last Verified 2026-07-10 Tier 1 Multi-Source Checked

Multi-Jurisdiction Regulatory Status

Official licensing, rolling submissions, or authorization status tracked across major health authorities.

Regulatory Authority	Status & Details
US FDA	Not Filed / Pre-submission
EMA (Europe)	Not Filed / Pre-submission
Health Canada	Not Filed / Pre-submission
TGA (Australia)	Not Filed / Pre-submission

Scientific Profile & Documentation

Platform Architecture: Biological (unspecified platform)
Lead Developer: CanSino Biologics Inc.
Next Expected Milestone: Primary completion (most advanced trial): 2025-12 (registry estimate)
Analyst & Development Notes: Auto-grouped from 4 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation: ClinicalTrials.gov NCT06389513 →
Additional Sources & Literature: NCT05935176 on ClinicalTrials.gov (2026-07-10)
NCT06226714 on ClinicalTrials.gov (2026-07-10)
NCT06700148 on ClinicalTrials.gov (2026-07-10)

Registered Clinical Trials & Studies

Direct registry links to active, completed, or pivotal registration studies across phases.

NCT06389513 Phase 3 Clinical Trial

Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

Status: Active / Ongoing • Expected Readout: 2025-12

NCT05935176 Phase 3 Clinical Trial

Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector

Status: Active / Ongoing • Expected Readout: 2026-05-15

NCT06226714 Phase 3 Clinical Trial

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

Status: Active / Ongoing • Expected Readout: 2024-09-26

NCT06700148 Phase 3 Clinical Trial

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

Status: Active / Ongoing • Expected Readout: 2025-08-30

Milestone Overview

Stage Verification

Phase 3 Clinical Trial confirmed as of 2026-07-10.
Target Milestone

Primary completion (most advanced trial): 2025-12 (registry estimate)

Vaccine Data Navigator Candidate Profile Registry:

This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.