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 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.

Study Overview

• Status: Completed
• Conditions: Vaccine Reaction; Poliomyelitis
• Intervention / Treatment: Biological: Eupolio

• Study Type: Interventional
• Enrollment (Actual): 2001
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Cavite City, Philippines
    • Health Index Multispecialty and Lying-in Clinic
  • Gov, D, Nabgybat Ave, Philippines
    • De La Salle Medical and Health Sciences Institue
  • Manila, Philippines
    • University of the Philippines - Philippine General Hospital
  • Metro Manila, Philippines
    • Tropical Disease Foundateion, Inc.
  • Quezon City, Philippines
    • Philippine Heart Center
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Bangkok, Thailand
    • Faculty of Medicine, Chulalongkorn University
  • Chiang Mai, Thailand
    • Faculty of Medicine, Chiang Mai University
  • Khon Kaen, Thailand
    • Khon Kaen University, Srinagarind Hospital
  • Songkhla, Thailand
    • Hatyai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety group; 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; Inactivated Polio vaccine (Sabin strains)
Experimental: Immunogenicity group 1 (4 Eupolio including 1 boosting dose); 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; Inactivated Polio vaccine (Sabin strains)
Experimental: Immunogenicity group 2 (3bOPV+2 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited adverse event	Expected local or systemic side effects after vaccination	7 days after each vaccination
Unsolicited adverse event	All unwanted or bad events after vaccination other than solicited adverse event	28 days after each vaccinations
Immediate reaction	Any side effects that occur within 30 minutes after the vaccination	30 minutes after each vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rate	Proportion of infants who have more than 8 protective antibody titers	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	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.	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.	4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Infections; RNA Virus Infections; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Central Nervous System Infections; Myelitis; Poliomyelitis
• Other Study ID Numbers: LG-VCCL002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No