Actively Recruiting
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
Led by Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) · Updated on 2026-04-06
30
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female participants aged 18 to 50 years who can provide valid legal identification
- Willing and able to give written informed consent and understand the study purpose and risks
- Willing and able to comply with all study procedures and available for the entire study duration
- Body Mass Index between 18.0 and 32.0 kg/m2 at screening
- Female participants must either not be of childbearing potential or have a negative pregnancy test and agree to use effective contraception or abstinence during the study
- Female participants should not be breastfeeding during the study
- Male participants must agree to abstinence, surgical sterilization, condom use with partners of childbearing potential, or be in an exclusively same-sex relationship, and agree not to donate sperm during the study
You will not qualify if you...
- Oral temperature above 37.5°C at screening or before vaccination
- Previous vaccination with any Group B meningococcal vaccine or history of invasive Neisseria meningitidis disease
- Abnormal clinical findings deemed significant by investigators
- Known allergy or severe reaction to vaccine components
- Vaccination with live or other vaccines within specified days before study vaccination
- Acute or worsening chronic illness within 3 days before vaccination
- Use of certain medications or immunomodulators before or during the study
- Receipt of blood products or immunoglobulins within 3 months before vaccination
- Recent blood donation or loss exceeding 450 mL within 30 days before screening
- Severe underlying diseases or ongoing medical conditions that increase risk or interfere with study
- Neurological or significant psychiatric disorders
- Contraindications to intramuscular injections
- Asplenia or splenectomy
- Planned relocation or prolonged absences during study
- Participation in other clinical trials involving investigational products within 30 days before or during this study
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis at screening
- Skin conditions affecting assessment at injection sites
- Any other condition impacting study assessment or safety as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linear Early Phase Limited
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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