Actively Recruiting
Phase IV Clinical Study Comparing Immunogenicity and Safety of Single-dose Inactivated Poliovirus Vaccine (sIPV) in Adolescents and Adults Aged 7-50 Years Versus Three-dose DTaP-IPV-Hib Vaccine in Infants
Led by Sinovac Biotech Co., Ltd · Updated on 2026-01-21
180
Participants Needed
3
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the immune response and safety of a single dose of the inactivated poliovirus vaccine (sIPV) in healthy adolescents and adults aged 7 to 50 years with the standard three-dose pentavalent vaccine (DTaP-IPV-Hib) given to infants aged 3 months. This Phase IV, open-label study will include 180 participants divided into three groups: 60 adolescents, 60 adults, and 60 infants. The study aims to evaluate how well these vaccines stimulate immunity against poliovirus and other components. Participants aged 7 to 50 years will receive one intramuscular dose of sIPV on Day 0, while infants will receive three doses of the pentavalent vaccine at 3, 4, and 5 months of age. Blood samples will be collected before vaccination and 30 days after the last vaccine dose to measure antibody levels. The study will also monitor for any adverse events immediately after vaccination and for up to 30 days post-vaccination, including serious adverse events and pregnancy occurrences in fertile participants. Throughout the study, researchers will collect blood samples and observe participants for side effects using diary cards and follow-up contacts. Immunogenicity will be assessed by measuring antibody responses against poliovirus and other vaccine components. Safety will be closely monitored during and after vaccination. The total participation duration varies by group but includes multiple visits for vaccination, blood collection, and safety evaluations. This study is sponsored by Sinovac Biotech Co., Ltd and runs until May 2026.
CONDITIONS
Brief 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
- Ability to understand and voluntarily sign informed consent (participants aged 7-17 years and their guardians must both sign)
- Provide valid proof of identity
- Willing and able to comply with all visits, sample collections, vaccinations, and study procedures
- Fertile participants and their sexual partners agree to use 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 polio or polio infection
- Exposure or suspected exposure to pertussis, diphtheria, or tetanus within the past 30 days (infants only)
- History of uncontrolled chronic or severe illnesses including cardiovascular, blood, liver, kidney, digestive, respiratory diseases, malignant tumors, or major organ transplantation
- Autoimmune diseases or immunodeficiencies such as lupus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, and HIV infection
- Abnormal blood clotting
- Premature birth before 37 weeks, low birth weight under 2500g, history of asphyxiation, or neurological damage (infants only)
- Severe congenital malformations, genetic defects, or malnutrition
- Severe neurological or psychiatric disorders, or family history of psychiatric disorders
- Acute worsening of any disease or active infection within past 3 days
- Previous vaccination with vaccines containing DTP, IPV, Hib, or pneumococcal polysaccharide conjugate vaccine (infants only)
- Immunosuppressive or immunomodulatory treatment for 14 or more days in past 6 months or planned during study
- Immunoglobulin or blood product treatment in past 6 months or planned during study
- Use of investigational drugs or vaccines within past 30 days or planned during study
- Live attenuated or nucleic acid vaccines within past 14 days, or subunit/inactivated vaccines within past 7 days
- Known allergy to any vaccine components
- Breastfeeding, pregnancy, or planning pregnancy within 3 months after vaccination (adolescents and adults only)
- Fever over 37.0°C on vaccination day
- Unqualified physical exam on vaccination day
- Skin problems at injection site
- Other factors deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 2 months depending on age group vaccination schedule
Participants receive vaccination according to their age group: adolescents and adults aged 7-50 years receive one dose of sIPV vaccine on Day 0, while infants aged 3 months receive three doses of DTaP-IPV-Hib vaccine at 3, 4, and 5 months of age.
1 visit for sIPV dose (in-person); 3 visits for DTaP-IPV-Hib doses (in-person) at 3, 4, and 5 months of age
Duration - 30 days after last vaccination
Participants are observed for adverse events and serious adverse events for 30 days after the last vaccination. Blood samples are collected before vaccination and at Day 30 after the last vaccination for antibody testing and immunogenicity evaluation. Pregnancy events are monitored for fertile participants throughout the study period.
2 visits for blood sample collection (before vaccination and Day 30 post last vaccination); daily monitoring of adverse events from Day 0 to Day 7 and ongoing adverse event reporting through Day 30
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
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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