Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study (NCT03722004) | Clinical Trial Compass
CompletedPhase 4
Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study
Bangladesh1,256 participantsStarted 2018-12-18
Plain-language summary
This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.
Who can participate
Age range
35 Days – 41 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 infants 5 weeks of age (range: 35-41 days).
* Parents that consent for participation in the full length of the study.
* Parents that are able to understand and comply with planned study procedures.
Exclusion Criteria:
* Parents and infants who are unable to participate in the full length of the study.
* A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
* A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of fIPV or collection of blood by venipuncture.
* Evidence of a chronic medical condition identified by a study medical officer during physical exam.
* Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
* Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
* Known allergy/sensitivity or reaction to polio vaccine, or its contents.
* Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
* Infants from premature births (\<37 weeks of gestation).
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
Vaccine response
Timeframe: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.
2
Vaccine virus particles
Timeframe: Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age.