drugset / Trial / NCT02785705
Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine
Phase 3
Completed
600 enrolled
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Air Force Military Medical University, China · collabBeijing Tiantan Biological Products Co., Ltd. · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
Timeline
- Start
- 2015-04
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bivalent types 1 and 3 oral poliovirus vaccine | Vaccine | — | Oral |
| Subject | trivalent conventional inactivated poliovirus vaccine | Vaccine | — | — |
| Subject | trivalent types 1, 2 and 3 oral poliovirus vaccine | Vaccine | — | Oral |