PoliomyelitisPhase 3NCT05431933
Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants
A Phase 3 study testing Eupolio in people with Poliomyelitis and Vaccine Reaction, run by LG Chem at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Vaccine Reaction
- What is being tested?
- Eupolio
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,001 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 10 Jan 2023to 6 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants in stable health
- Male or female 6 to 8 weeks of age
- Signed informed consent by the infant's parent(s) or legally acceptable representative(s)
Who cannot join
- Known or suspected poliomyelitis
- Known or suspected febrile(symptom of a fever), or chronic illnesses
- Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
- Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
- Previous use of blood or blood-derived products
- Previous use of polio vaccines
Show all 11Show fewer
- Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)
- Bleeding disorders
- Household contact or intimate exposure with a confirmed case of polio
- Any history of allergy (hypersensitivity) to the components of the polio vaccine
- Participation in another interventional clinical trial simultaneously or within 30 days
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Philippines5 sites
Health Index Multispecialty and Lying-in Clinic
Cavite City
De La Salle Medical and Health Sciences Institue
Gov, D, Nabgybat Ave
University of the Philippines - Philippine General Hospital
Manila
Tropical Disease Foundateion, Inc.
Metro Manila
Philippine Heart Center
Quezon City
Thailand5 sites
Faculty of Medicine, Chulalongkorn University
Bangkok
Siriraj hospital
Bangkok
Faculty of Medicine, Chiang Mai University
Chiang Mai
Khon Kaen University, Srinagarind Hospital
Khon Kaen
Hatyai Hospital
Songkhla
About this study
Official title: A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants
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.
- Conditions
- Poliomyelitis, Vaccine Reaction
- Being tested
- Eupolio
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EupolioBiological
Inactivated Polio vaccine (Sabin strains)
| Study group | Role | What they receive |
|---|---|---|
| Safety group | Experimental | Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm. Receives: Biological: Eupolio |
| Immunogenicity group 1 (4 Eupolio including 1 boosting dose) | Experimental | 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. Receives: Biological: Eupolio |
| Immunogenicity group 2 (3bOPV+2 Eupolio) | Experimental | bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age. Receives: Biological: Eupolio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate reaction
Any side effects that occur within 30 minutes after the vaccination
Measured: 30 minutes after each vaccination
Solicited adverse event
Expected local or systemic side effects after vaccination
Measured: 7 days after each vaccination
Unsolicited adverse event
All unwanted or bad events after vaccination other than solicited adverse event
Measured: 28 days after each vaccinations
Secondary outcomes (4)
Seroprotection rate
Proportion of infants who have more than 8 protective antibody titers
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start10 Jan 2023
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431933
- Sponsor's protocol ID
- LG-VCCL002
- Status last verified
- Apr 2025
- First submitted
- 17 Jun 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants
- ClinicalTrials.gov ID
- NCT05431933
- Acronym / sponsor ID
- LG-VCCL002
- Conditions
- Poliomyelitis, Vaccine Reaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety group | Experimental | Biological: EupolioThree doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm. |
| Immunogenicity group 1 (4 Eupolio including 1 boosting dose) | Experimental | Biological: EupolioThree 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. |
| Immunogenicity group 2 (3bOPV+2 Eupolio) | Experimental | Biological: EupoliobOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants in stable health
- Male or female 6 to 8 weeks of age
- Signed informed consent by the infant's parent(s) or legally acceptable representative(s)
Key exclusion criteria (11 listed)
- Known or suspected poliomyelitis
- Known or suspected febrile(symptom of a fever), or chronic illnesses
- Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
- Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
- Previous use of blood or blood-derived products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EupolioInactivated Polio vaccine (Sabin strains) | Biological | Immunogenicity group 1 (4 Eupolio including 1 boosting dose), Immunogenicity group 2 (3bOPV+2 Eupolio), Safety group |
Primary outcome
Immediate reaction
Time frame: 30 minutes after each vaccination
Any side effects that occur within 30 minutes after the vaccination
Solicited adverse event
Time frame: 7 days after each vaccination
Expected local or systemic side effects after vaccination
Unsolicited adverse event
Time frame: 28 days after each vaccinations
All unwanted or bad events after vaccination other than solicited adverse event
4 secondary outcomes
Seroprotection rate
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
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
Time frame: 7 days after the boosting vaccination in the 4 Eupolio group
Seroconversion rate
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Poliomyelitis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Poliomyelitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eupolio in people with Poliomyelitis and Vaccine Reaction, run by LG Chem at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Philippines, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate reaction (time frame: 30 minutes after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.