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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

NCT07135986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1602

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.

Study details include:

* The study duration will be approximately 180 days.
* The vaccination visit will be Visit 1.
* The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

Conditions

  • Meningococcal Infection
  • Healthy Volunteers

Interventions

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection

BIOLOGICAL

MenACYW135 polysaccharide vaccine

Pharmaceutical form: Lyophilized powder-Route of administration:IM injection

BIOLOGICAL

MenAC conjugate vaccine

Pharmaceutical form:Lyophilized powder-Route of administration:IM injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2026-05-01
Completion
2026-09-23
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT07135986 on ClinicalTrials.gov