A Phase 3 interventional study of Eupolio in Poliomyelitis and Vaccine Reaction, sponsored by LG Chem. Completed at 10 sites in 2 countries. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by LG Chem · Phase 3, Interventional, and Prevention
Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated.
As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 2,001 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.
Biological: Eupolio
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.
Biological: Eupolio
bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.
Biological: Eupolio
Inactivated Polio vaccine (Sabin strains)
Immediate reaction
Any side effects that occur within 30 minutes after the vaccination
Time frame: 30 minutes after each vaccination
Solicited adverse event
Expected local or systemic side effects after vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse event
All unwanted or bad events after vaccination other than solicited adverse event
Time frame: 28 days after each vaccinations
Seroprotection rate
Proportion of infants who have more than 8 protective antibody titers
Time frame: 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group
Geometric mean titers of neutralizing antibody against polio antigens
Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3
Time frame: 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group
Priming response
Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.
Time frame: 7 days after the boosting vaccination in the 4 Eupolio group
Seroconversion rate
Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.
Time frame: 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Nov 2024, 21 months.
Of 35 industry-sponsored phase 3 interventional studies under Poliomyelitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 21. This study's 21 months is above that.
Counting every sponsor, half of 44 studies reached it within 12 months; a quarter within 7 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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