drugset / Trial / NCT03614702
Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV
Phase 3
Completed
1200 enrolled
Institute of Medical Biology, Chinese Academy of Medical Sciences
Guangxi Center for Disease Control and Prevention · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) are required to use in the "Strategy of Polio Eradication \& Endgame Strategic Plan 2013-2018" worldwide. To evaluate the safety and immunogenicity by different sequential schedules of bOPV/tOPV with IPV(sIPV/cIPV), a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month-old in Guangxi Province, China.
Timeline
- Start
- 2015-09-15
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inactivated Poliomyelitis Vaccine Made from Sabin Strains | Vaccine | 0.5 ml | Intramuscular |
| Subject | Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains | Vaccine | 0.5 ml | Intramuscular |
| Subject | Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 | Vaccine | 0.1 ml | Oral |
| Subject | Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 | Vaccine | 1 g | Oral |
| Subject | bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 | Vaccine | 0.1 ml | Oral |
| Subject | bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 | Vaccine | 1 g | Oral |