drugset / Trial / NCT05654467
Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
Phase 2
Recruiting
1532 enrolled
PATH
Bill and Melinda Gates Foundation · collabCenters for Disease Control and Prevention · collabPT Bio Farma · collabTechnical Resources International, Inc. · 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 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).
Timeline
- Start
- 2023-12-05
- Primary completion
- 2027-03-20
- Completion
- 2027-03-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine | Vaccine | 316228 unknown | Oral |
| Subject | Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine | Vaccine | 1e+06 unknown | Oral |
| Subject | Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine | Vaccine | 3.16228e+06 unknown | Oral |
| Subject | Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 | Vaccine | 630957 unknown | Oral |