Status:
COMPLETED
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
Lead Sponsor:
LG Chem
Conditions:
Poliomyelitis
Vaccine Reaction
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
2001 Patients enrolled
Trial Details
Trial ID
NCT05431933
Start Date
January 10 2023
End Date
November 6 2024
Last Update
April 6 2025
Active Locations (10)
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1
Health Index Multispecialty and Lying-in Clinic
Cavite City, Philippines
2
De La Salle Medical and Health Sciences Institue
Gov, D, Nabgybat Ave, Philippines
3
University of the Philippines - Philippine General Hospital
Manila, Philippines
4
Tropical Disease Foundateion, Inc.
Metro Manila, Philippines