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A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104

NCT07395739 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-06

No results posted yet for this study

Summary

A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.

Conditions

  • Neisseria Meningitidis Serogroup B

Interventions

BIOLOGICAL

Bexsero®

Intramuscular injection; 0.5ml/pre-filled syringe. Administer the vaccine according to the 0, 1, 6-month schedule.

BIOLOGICAL

Group B Meningococcal OMV Vaccine

Intramuscular injection; 0.5ml/vial. Administer the vaccine according to the 0, 1, 6-month schedule.

Sponsors & Collaborators

  • Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2027-05-01
Completion
2027-07-01

Countries

  • Australia

Study Locations

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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 NCT07395739 on ClinicalTrials.gov