Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations (NCT07354269) | Clinical Trial Compass
RecruitingPhase 4
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
China180 participantsStarted 2025-09-26
Plain-language summary
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
Who can participate
Age range3 Months – 50 Years
SexALL
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Inclusion criteria
✓. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
✓. Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
✓. 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 period;
✓. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.
Exclusion criteria
✕. Known history of polio/polio infection.
✕. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
✕. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.
✕. Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
What they're measuring
1
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years
Timeframe: day 30 after the single dose vaccination
2
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years
Timeframe: day 30 after the single dose vaccination
3
The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Timeframe: day 30 after the single dose vaccination
. Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
✕. Premature birth (delivery before the 37th week of gestation) or low birth weight (birth weight \<2500g), or history of asphyxiation, or history of neurological damage (applies to infants aged 3 months).
✕. Severe congenital malformations, genetic defects, and malnutrition.
✕. Current or past history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding a history of febrile seizures\]) or psychiatric disorders, or family history of psychiatric disorders.