A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poli… (NCT06752174) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
China300 participantsStarted 2023-03-08
Plain-language summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
Who can participate
Age range
60 Days – 90 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
. Infant's legal guardians agree to sign the informed consent forms voluntarily;
. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
. Armpit temperature ≤ 37.0 ℃
Exclusion criteria
. Preterm birth (delivery before the 37th week of pregnancy).
. Previous vaccination against polio.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
. History of polio.
. History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
. History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
. Individuals with immunodeficiency or receiving immunosuppression therapy.
. Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.