Trail To Evaluate the Immune Effects of Primary and Booster Immunizations With Poliovirus Vaccine (NCT03821441) | Clinical Trial Compass
UnknownPhase 3
Trail To Evaluate the Immune Effects of Primary and Booster Immunizations With Poliovirus Vaccine
China1,165 participantsStarted 2018-01-04
Plain-language summary
Trail To Evaluate the Immunity Duration of healthy children who already took part in " The safety and immunogenicity by different sequential schedules of bOPV and bOPV in dragee candy with sIPV, a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month old in Guangxi Province, China" and continue to search for the effects of booster immunization.
Who can participate
Age range
24 Months – 48 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:
* Subjects who have already taken part in phase 3 clinical trail in Guangxi and were vaccinated 3-dose primary immunization with polio vaccines .Moreover，the results of the selected paired serum are required.
* 24 months old(calendar month).
* Guardians understand the contents and requirements of this trail , meanwhile, voluntarily joined this study with informed consents.
* Able to attend all scheduled visits and to comply with all trial procedures(including vaccinate and blood collection)
Exclusion Criteria:
* Any booster immunization with polio vaccine after finishing 3-dose primary immunizations research.
* Polio virus infection was demonstrated in laboratory experiment.
* Participation in another clinical trial at the same times.
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives or increase the risk of subjects,such as acute or chronic diseases 、some abnormal detected by lab,and so on.
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.