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
Overview
- Phase
- Phase 3
- Intervention
- Eupolio
- Conditions
- Poliomyelitis
- Sponsor
- LG Chem
- Enrollment
- 2001
- Locations
- 10
- Primary Endpoint
- Immediate reaction
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Safety group
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.
Intervention: Eupolio
Immunogenicity group 1 (4 Eupolio including 1 boosting dose)
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.
Intervention: Eupolio
Immunogenicity group 2 (3bOPV+2 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.
Intervention: Eupolio
Outcomes
Primary Outcomes
Immediate reaction
Time Frame: 30 minutes after each vaccination
Any side effects that occur within 30 minutes after the vaccination
Unsolicited adverse event
Time Frame: 28 days after each vaccinations
All unwanted or bad events after vaccination other than solicited adverse event
Solicited adverse event
Time Frame: 7 days after each vaccination
Expected local or systemic side effects after vaccination
Secondary Outcomes
- Priming response(7 days after the boosting vaccination in the 4 Eupolio group)
- 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)
- 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)
- 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)