Actively Recruiting
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
Led by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · Updated on 2023-09-21
1920
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
CONDITIONS
Official Title
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals aged 2 years and older, confirmed by medical history and physical examination
- Participants or their legal guardians voluntarily agree and sign informed consent; participants aged 8-17 years also sign an informed notification
- Participants and/or guardians can comply with clinical protocol requirements
- Axillary body temperature below 37.3°C on enrollment day; visits may be rescheduled if not met
You will not qualify if you...
- Previous vaccination with any marketed or experimental pneumococcal vaccine
- History of invasive pneumococcal disease confirmed by culture
- Personal or family history of convulsions, epilepsy, encephalopathy, or mental illness
- Severe allergy to any vaccine or drug, allergy to vaccine ingredients, or history of vaccination-related fever of 39°C or higher
- Known severe congenital malformations, developmental disabilities, or serious chronic diseases (e.g., Down syndrome, uncontrolled diabetes, sickle cell anemia, Guillain-Barré syndrome)
- Known or suspected serious diseases including severe respiratory, digestive, endocrine, cardiovascular, liver, kidney, malignant tumors, or severe skin diseases
- Immune system disorders or immunosuppressant treatment within 6 months (including radiotherapy, chemotherapy, corticosteroids, HIV infection)
- Treatment with blood products or globulin within 3 months before enrollment (except hepatitis B immune globulin)
- Asplenia, functional asplenia, or splenectomy
- Acute infection or exacerbation of chronic disease within 3 days before enrollment, or planned steroid use within 1 month after vaccination
- Use of antipyretic analgesics or anti-allergic drugs within 3 days before enrollment
- Pregnant, breastfeeding, or planning pregnancy within 6 months (women of childbearing age)
- Uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg) in adults 18 years and older before enrollment
- Receipt of attenuated live vaccines within 14 days or inactivated vaccines within 7 days before vaccination
- Participation or planned participation in other drug or vaccine clinical studies within 6 months after vaccination
- Investigator's judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xuecheng LIU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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