Actively Recruiting
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
Led by Sinovac Biotech Co., Ltd · Updated on 2026-01-21
180
Participants Needed
3
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months
CONDITIONS
Official Title
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months
- Participants and/or their guardians able to understand and voluntarily sign informed consent (both participant and guardian must sign for ages 7-17 years)
- Provide valid proof of identity
- Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study
- Fertile participants and their partners agree to effective contraception from consent signing until 3 months after vaccination and have no plans to donate sperm or eggs
You will not qualify if you...
- History of poliomyelitis or polio infection
- Exposure or suspected exposure to pertussis, diphtheria, or tetanus within the past 30 days (applies to infants aged 3 months)
- History of uncontrolled chronic or severe illnesses such as cardiovascular, hematological, liver, kidney, digestive, respiratory diseases, malignant tumors, or major organ transplant
- Presence of autoimmune diseases or immunodeficiency disorders including lupus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, or HIV infection
- Abnormal blood clotting function
- Premature birth (before 37 weeks), low birth weight (<2500g), history of asphyxia, or neurological damage (infants aged 3 months)
- Severe congenital malformations, genetic defects, or malnutrition
- Current or past severe neurological or psychiatric diseases, or family history of psychiatric disorders
- Acute worsening of diseases or active infections within past 3 days
- Previous vaccination with any vaccine containing DTP, IPV, Hib, or pneumococcal conjugate vaccine (infants aged 3 months)
- Immunosuppressive treatment or cytotoxic therapy within the past 6 months or planned during the study
- Immunoglobulin or blood product treatment within past 6 months or planned during study
- Use of investigational drugs or vaccines within past 30 days or planned
- Use of live attenuated or nucleic acid vaccines within 14 days, or subunit/inactivated vaccines within 7 days
- Known allergy to any component of the study vaccines
- Breastfeeding, pregnant, or planning pregnancy within 3 months after vaccination (adolescents and adults)
- Axillary temperature above 37.0°C on vaccination day
- Unqualified physical exam on vaccination day
- Skin problems at injection site that may interfere with vaccination or reaction observation
- Any other factors the investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Longxi County Center for Disease Prevention and Control, Dingxi City
Dingxi, Gansu, China
Actively Recruiting
2
Chengguan District Center for Disease Prevention and Control, Lanzhou City
Lanzhou, Gansu, China
Actively Recruiting
3
Zhangye Center for Disease Prevention and Control
Zhangye, Gansu, China
Actively Recruiting
Research Team
X
Xiaoshu Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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