Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV (NCT06114810) | Clinical Trial Compass
UnknownPhase 4
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV
880 participantsStarted 2023-11
Plain-language summary
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:
1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
2. Separation of bOPV and nOPV2 with an interval of 4 weeks.
Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
Who can participate
Age range
42 Days – 48 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 6 weeks of age
. Parents that consent for participation in the full length of the study.
. Parents that can understand and comply with planned study procedures.
Exclusion criteria
. Parents and infants 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
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
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.
Timeframe: Serology: 6 &18 weeks
Trial details
NCT IDNCT06114810
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh