Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Pol… (NCT07457060) | Clinical Trial Compass
RecruitingPhase 4
Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
Philippines480 participantsStarted 2025-11-27
Plain-language summary
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Who can participate
Age range
56 Days – 84 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
. Infants of 2 months old (aged 56-84 days).
. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
. Be able to provide the vaccination records since birth.
. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Exclusion criteria
. History of any polio vaccination.
. History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
. Premature infants (born before week 37 of gestation).
. History of asphyxia rescue or nervous system injury.
. Autoimmune diseases or immunodeficiency/immunosuppression.
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 SPR of nab against polioviruses of three types at day 28 after three doses of vaccination
Timeframe: day 28 after three doses of vaccination
2
The frequency of adverse reactions within 28 days after vaccination