Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety group | Experimental | 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) | Experimental | 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) | Experimental | bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eupolio | Biological | Inactivated Polio vaccine (Sabin strains) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate reaction | Any side effects that occur within 30 minutes after the vaccination | 30 minutes after each vaccination |
| Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination |
| Unsolicited adverse event | All unwanted or bad events after vaccination other than solicited adverse event | 28 days after each vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate | Proportion of infants who have more than 8 protective antibody titers | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Index Multispecialty and Lying-in Clinic | Cavite City | Philippines | ||||
| De La Salle Medical and Health Sciences Institue |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Geometric mean titers of neutralizing antibody against polio antigens |
Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3 |
| 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 |
| Priming response | Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose. | 7 days after the boosting vaccination in the 4 Eupolio group |
| Seroconversion rate | Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination. | 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group |
| Gov, D, Nabgybat Ave |
| Philippines |
| University of the Philippines - Philippine General Hospital | Manila | Philippines |
| Tropical Disease Foundateion, Inc. | Metro Manila | Philippines |
| Philippine Heart Center | Quezon City | 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 |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided