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
- Conditions
- PoliomyelitisVaccine Reaction
- Interventions
- Biological: Eupolio
- Registration Number
- NCT05431933
- Lead Sponsor
- LG Chem
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2001
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Safety group Eupolio Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm. Immunogenicity group 1 (4 Eupolio including 1 boosting dose) Eupolio 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. Immunogenicity group 2 (3bOPV+2 Eupolio) Eupolio bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.
- Primary Outcome Measures
Name Time Method Immediate reaction 30 minutes after each vaccination Any side effects that occur within 30 minutes after the vaccination
Unsolicited adverse event 28 days after each vaccinations All unwanted or bad events after vaccination other than solicited adverse event
Solicited adverse event 7 days after each vaccination Expected local or systemic side effects after vaccination
- Secondary Outcome Measures
Name Time Method Priming response 7 days after the boosting vaccination in the 4 Eupolio group Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.
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 Proportion of infants who have more than 8 protective antibody titers
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 Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3
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 Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.
Trial Locations
- 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
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
Philippine Heart Center
🇵🇭Quezon City, Philippines