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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05431933•LG Chem

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

Locations (10)

Health Index Multispecialty and Lying-in Clinic

Cavite City, Philippines

De La Salle Medical and Health Sciences Institue

Gov, D, Nabgybat Ave, Philippines

University of the Philippines - Philippine General Hospital

Manila, Philippines

Tropical Disease Foundateion, Inc.

Metro Manila, Philippines

Philippine Heart Center

Quezon City, Philippines

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Siriraj hospital

Bangkok, Thailand

Faculty of Medicine, Chiang Mai University

Chiang Mai, Thailand

Khon Kaen University, Srinagarind Hospital

Khon Kaen, Thailand

Hatyai Hospital

Songkhla, Thailand

Key Dates

Start Date

January 10, 2023

Primary Completion Date

November 6, 2024

Completion Date

November 6, 2024

Last Updated

April 6, 2025

Enrollment

2,001

ACTUAL participants

Conditions

PoliomyelitisVaccine Reaction

Interventions

Eupolio

BIOLOGICAL

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

NCT05644184

Poliomyelitis

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RECRUITINGPHASE2/PHASE3

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

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DiphtheriaTetanus+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study