Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
Summary
The main objectives of this study are to : * evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Timeline
- Start
- 2024-11-20
- Primary completion
- 2027-12-15
- Completion
- 2027-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bivalent Oral Poliomyelitis Vaccine (bOPV) | Unknown | 630957 unknown | Oral |
| Comparator | Bivalent Oral Poliomyelitis Vaccine (bOPV) | Unknown | 1e+06 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 1 (nOPV1) | Unknown | 1e+06 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 1 (nOPV1) | Unknown | 3.16228e+06 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 2 (nOPV2) | Unknown | 199526 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 2 (nOPV2) | Unknown | 398107 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 3 (nOPV3) | Unknown | 1e+06 unknown | Oral |
| Subject | Novel oral poliomyelitis vaccine type 3 (nOPV3) | Unknown | 3.16228e+06 unknown | Oral |