Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07354269
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
2. 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);
3. Provide valid proof of identity;
4. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
5. 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:
1. Known history of polio/polio infection.
2. 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).
3. 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.
4. 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).
5. Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
6. 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).
7. Severe congenital malformations, genetic defects, and malnutrition.
8. 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.
9. Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.
10. History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).
11. Received immunosuppressive or other immunomodulatory treatment for ≥14 days within the past 6 months (≥20mg/day of prednisone for those ≥18 years old, ≥2mg/kg/day for those \<18 years old, or equivalent doses), cytotoxic treatment, or plans to receive such treatment during the study.
12. Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.
13. Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.
14. Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
15. Known allergy to any component of the study vaccine (inactivated poliovirus, 199 medium, glycine, sodium chloride, potassium chloride, calcium chloride, magnesium phosphate, disodium phosphate, monosodium phosphate \[for adolescents and adults\]; inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous hemagglutinin, Haemophilus influenzae type b capsular polysaccharide, tetanus protein conjugate \[for infants aged 3 months\]).
16. Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults).
17. Axillary temperature \>37.0°C before vaccination on the day of the planned vaccination with the study vaccine.
18. Unqualified physical examination results on the day of the planned vaccination with the study vaccine.
19. Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions.
20. Any other factors deemed unsuitable for participation in the clinical study by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
50 Years
Study:
NCT07354269
Study Brief:
Protocol Section:
NCT07354269