Immunogenicity of After Primary Immunization and Booster Immunization of sIPV (NCT06058429) | Clinical Trial Compass
UnknownNot Applicable
Immunogenicity of After Primary Immunization and Booster Immunization of sIPV
China233 participantsStarted 2023-08-16
Plain-language summary
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.
Who can participate
Age range
2 Months – 27 Months
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:
* Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
* Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
* There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
* The guardian of subjects need to agree to sign the informed consent form.
Exclusion Criteria:
* The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
* Subjects were participating in other clinical studies of vaccines or drugs;
* Other conditions that make subjects unsuitable for participating in this study judged by investigator's
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
Antibody positivity rate of sIPV vaccine after primary immunization in infants
Timeframe: 1 month
2
Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children
Timeframe: 1 month
3
seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children