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The objective of this study is to compare the antibody response 30 days after two doses of t OPV
The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tOPV commercial batch (Bio Farma) | Active Comparator | tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml) |
|
| tOPV pilot batch | Experimental | tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tOPV pilot batch | Biological | the tOPV vaccine is given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the antibody response 30 days after two doses of tOPV | antibody titer to Polio | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To asses and compare the safety of tOPV | Data collection of local and systemic reaction after immunization | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the antibody response after two doses of tOPV | Measurement of titer antibody | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eddy Fadlyana, MD | Department of Child Health of Medicine Padjadjaran University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garuda Primary Health Center | Bandung | West Java | Indonesia | |||
| Ibrahim Adjie Primary Health Centre |
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| ID | Term |
|---|---|
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| tOPV commercial batch | Biological | tOPV vaccine is given orally |
|
|
| Bandung |
| West Java |
| Indonesia |
| Padasuka Primary Health Centre | Bandung | West Java | Indonesia |
| Puter Primary Health Centre | Bandung | West Java | Indonesia |
| D045424 |
| Complex Mixtures |