MedTrace Logo

A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

NCT06131554 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1480

Last updated 2025-04-03

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

Conditions

  • Meningococcal Meningitis

Interventions

BIOLOGICAL

batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

batch 2 of MCV4

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

batch 3 of MCV4

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Isti Suharjanti, Dr · Husada Utama Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2024-07-12
Completion
2025-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

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 NCT06131554 on ClinicalTrials.gov