drugset / Trial / NCT05644184
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Phase 2
Recruiting
2232 enrolled
PATH
Bill and Melinda Gates Foundation · collabCenters for Disease Control and Prevention · collabDiagnoSearch Life Sciences Pvt. Ltd. · collabPT Bio Farma · collab
RandomizedSequentialQuadruple-blindPrevention
Summary
The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).
Timeline
- Start
- 2023-03-27
- Primary completion
- 2026-05-15
- Completion
- 2026-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mOPV1 | Vaccine | 1e+06 unknown | Oral |
| Subject | nOPV1 | Vaccine | 316228 unknown | Oral |
| Subject | nOPV1 | Vaccine | 1e+06 unknown | Oral |
| Subject | nOPV1 | Vaccine | 3.16228e+06 unknown | Oral |
| Subject | nOPV1 | Vaccine | 1e+07 unknown | Oral |
| Subject | nOPV1 | Vaccine | 3.16228e+08 unknown | Oral |