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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months

NCT07505836 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2026-04-01

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.

The main questions it aims to answer are:

Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.

Participants will:

Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.

Conditions

  • Epidemic Meningitis
  • Meningococcal Vaccines

Interventions

BIOLOGICAL

experimental vaccine

Group ACYW135 Meningococcal Conjugate Vaccine

BIOLOGICAL

Active Comparator vaccine

Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-22
Primary Completion
2027-01-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505836 on ClinicalTrials.gov