Poliomyelitis, Vaccine Reaction
Conditions
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.
Interventions
BIOLOGICALEupolio
Inactivated Polio vaccine (Sabin strains)
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate reaction | 30 minutes after each vaccination | Any side effects that occur within 30 minutes after the vaccination |
| Solicited adverse event | 7 days after each vaccination | Expected local or systemic side effects after vaccination |
| Unsolicited adverse event | 28 days after each vaccinations | All unwanted or bad events after vaccination other than solicited adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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. |
Countries
Philippines, Thailand
Outcome results
None listed