drugset / Trial / NCT06114810
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV
Phase 4
Unknown
880 enrolled
International Centre for Diarrhoeal Disease Research, Bangladesh
Centers for Disease Control and Prevention · collabGovernment of Bangladesh · collab
RandomizedSequentialOpen-labelPrevention
Summary
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV: 1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps; 2. Separation of bOPV and nOPV2 with an interval of 4 weeks. Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
Timeline
- Start
- 2023-11
- Primary completion
- 2024-06
- Completion
- 2024-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IPV | Vaccine | 0.5 ml | — |
| Comparator | bOPV | Vaccine | 0.1 ml | Oral |
| Comparator | nOPV2 | Vaccine | 0.1 ml | Oral |