CompletedPhase 3

A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals

Bangladesh1,120 participantsStarted 2016-06-08

Plain-language summary

Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.

Who can participate

Age range

42 Days – 83 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

. Normal healthy children of both sexes of age 5 to 6 years (60-83 months) at the time of vaccination and who have received at least 3 doses of trivalent oral polio vaccine (tOPV) based upon documentation (Study Part 1).
. Normal healthy infants of both sexes of age 6-8 weeks (42-56 days) at the time of the first vaccination and have not received oral polio vaccine (OPV) previously based upon documentation (Study Part 2).
. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
. Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
. Resident of study area.

Exclusion criteria

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

Part 1 study: Frequency of adverse events (AEs)

Timeframe: 4 Days

Part 2 study: Percentage of seroconversion to poliovirus type 1 and type 3

Timeframe: one month after dose 3

Part 1 study: Frequency of AEs and serious AEs (SAEs)

Timeframe: 28 days

Trial details

NCT IDNCT02766816

SponsorBilthoven Biologicals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-14

View on ClinicalTrials.gov More Immune Response to Oral Polio Vaccine trials