Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine (NCT03581734) | Clinical Trial Compass
UnknownPhase 3
Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine
Bangladesh579 participantsStarted 2018-07-01
Plain-language summary
Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available whole-cell killed Oral Cholera Vaccine (OCVs) with other oral vaccines, specifically, oral polio vaccines (OPV) is lacking. Although the risk of immunological interference due to co-administration of live vaccines with non-live vaccines is considered small if at all, a theoretical concern of interference has been raised. Given the substantial geographic correlation between polio- and cholera-affected and at-risk areas, which include some of the world's most impoverished and hard-to-reach populations, a strategy of co-administration of OCV with OPV to children targeted to receive OPVs has the potential to optimize the use of limited resources and improve coverage for both vaccines. The manufacturer recommendation for a two-week interval between administration of OPV and OCV precludes an integrated campaign or routine use in which OCV could be co-administered with OPV.
Who can participate
Age range
1 Year – 3 Years
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:
* Apparently healthy children aged 1 to 3 years of age. Family able to understand and comply with planned study procedures and consents to be in the study.
* Have received either no dose or only one dose of OPV ( 0 - 1 dose) and has not received any dose of IPV or OCV at any time before enrollment based upon immunization card record or history from parents.
Exclusion Criteria:
* Parents and children who are unable / unwilling to participate in the full length of the study for any reason.
* Child / family planning on moving away from the study area during the study period
* A diagnosis, suspicion of, or clinical condition consistent with an immunodeficiency disorder (either in the child or in a member of the immediate family) or is on long-term (\>3 months) of immunosuppressive therapy.
* A suspicion or known history of bleeding disorder that would contraindicate venipuncture.
* Acute diarrhea, infection or illness at the time of the first visit that would require the child's admission to a hospital or would contraindicate provision of OPV per country guidelines.
* History of severe allergic reaction to component of study vaccine
* Acute vomiting or diarrhea within 24 hours before the first visit.
* Severely malnourished children (Weight-for-age with z-score \< - 3 below the median of the WHO child growth standards.)
* Previously received 3 doses of OPV or single dose of IPV or OCV at any time before enrollment based upon immunization card record.
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
Anti-poliovirus antibodies
Timeframe: One year
2
Vibriocidal antibody response
Timeframe: One year
Trial details
NCT IDNCT03581734
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh