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New treatment option for Poliomyelitis
Official title Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
ClinicalTrials.gov ID: NCT07354269
What this study is testing
What is sIPV?
sIPV is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for poliomyelitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until...
You likely can't join if
- 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...
- History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney...
- Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis...
- 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...
See the full eligibility 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...
- 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...
- Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV...
- 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.
- Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.
- History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).
- 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)...
- Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.
- Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.
- Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
- 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...
- Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults).
- Axillary temperature \>37.0°C before vaccination on the day of the planned vaccination with the study vaccine.
- Unqualified physical examination results on the day of the planned vaccination with the study vaccine.
- Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions.
- Any other factors deemed unsuitable for participation in the clinical study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Dingxi, Gansu, China
- Lanzhou, Gansu, China
- Zhangye, Gansu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dingxi, Gansu, China; Lanzhou, Gansu, China; Zhangye, Gansu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.