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

NCT05431933 | Completed Phase 3 DMC

• 1 other identifier: LG-VCCL002
• Study Type: interventional
• Target: 2,001
• Locations: 2 countries
• Sites: 10

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Immediate reaction

  Any side effects that occur within 30 minutes after the vaccination

  30 minutes after each vaccination

• 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

Secondary Outcomes (4)

• Seroprotection rate

  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

  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

  7 days after the boosting vaccination in the 4 Eupolio group

• Seroconversion rate

  4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group

Study Arms (3)

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.

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.

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.

Biological: Eupolio

Interventions

Eupolio BIOLOGICAL

Inactivated Polio vaccine (Sabin strains)

Immunogenicity group 1 (4 Eupolio including 1 boosting dose); Immunogenicity group 2 (3bOPV+2 Eupolio); Safety group

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (10)

Health Index Multispecialty and Lying-in Clinic

Cavite City, Philippines

Location

De La Salle Medical and Health Sciences Institue

Gov, D, Nabgybat Ave, Philippines

Location

University of the Philippines - Philippine General Hospital

Manila, Philippines

Location

Tropical Disease Foundateion, Inc.

Metro Manila, Philippines

Location

Philippine Heart Center

Quezon City, Philippines

Location

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Location

Siriraj hospital

Bangkok, Thailand

Location

Faculty of Medicine, Chiang Mai University

Chiang Mai, Thailand

Location

Khon Kaen University, Srinagarind Hospital

Khon Kaen, Thailand

Location

Hatyai Hospital

Songkhla, Thailand

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: January 10, 2023
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (5); TH (5)