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

LG-VCCL002

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.

2023-01-10

2025-01-01

2025-01-01

Recruiting

Early phase I

2000

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

2023-03-09