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

LG Chem

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Vaccine Reaction

Treatments: Biological: Eupolio

Study type: Interventional

Funder types: Industry

Identifiers

NCT05431933

LG-VCCL002

Details and patient eligibility

About

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.

Enrollment: 2,001 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,001 participants in 3 patient groups

Safety group

Experimental group

Description:

Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.

Treatment:

Biological: Eupolio

Immunogenicity group 1 (4 Eupolio including 1 boosting dose)

Experimental group

Description:

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.

Treatment:

Biological: Eupolio

Immunogenicity group 2 (3bOPV+2 Eupolio)

Experimental group

Description:

bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.

Treatment:

Biological: Eupolio