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Sponsor decided not to conduct it
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bOPV dose | Active Comparator | Naïve infants to receive two doses of bOPV at 2 and 3 months of age. |
|
| nOPV2 dose | Active Comparator | Naïve infants to receive two doses of nOPV2 at 2 and 3 months of age. |
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| bOPV + nOPV2 dose | Experimental | Naïve infants to receive two doses of nOPV2 and bOPV at 2 and 3 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bOPV and nOPV2 | Biological | Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV | 2 months |
| Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs) | Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity to poliovirus type 2 | Assessment and comparison of geometric mean neutralizing antibody titers against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV | 2 months |
| Immunogenicity to poliovirus type 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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Assessment and comparison of seroconversion rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV |
| 2 months |
| Immunogenicity to poliovirus type 2 | Assessment and comparison of seroprotection rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV | 2 months |
| Assessment and comparison of immunogenicity to poliovirus type 1 and 3 | Assessment and comparison of the seroprotection rates against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV. | 2 months |
| Assessment and comparison of immunogenicity to poliovirus type 1 and 3 | Assessment and comparison of the geometric mean neutralizing against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV. | 2 months |
| Assesment of SAEs, IMEs and any AEs | Number, severity and causality of any serious adverse event (SAE), any solicited AE, any unsolicited AE and any important medical events (IME) following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV | 6 months |
| Assessment and comparison of viral shedding | Assessment and comparison of viral shedding in stool at fixed time points following administration of nOPV2, bOPV or the co-administration of nOPV2 and bOPV. | 1 month |
| 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 |