NCT04220515

Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49,731 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

Summary

This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).

Detailed description

For active safety monitoring in expanding populations, a total of 20,019 participants in Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) For passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sIPV by passive safety surveillance via AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via AEFI monitoring system and evaluated after 3-dose sIPV for primary immunization.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Poliomyelitis Vaccine Made From Sabin Strain	Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU

Timeline

• Start date: 2018-02-08
• Primary completion: 2019-08-08
• Completion: 2019-10-14
• First posted: 2020-01-07
• Last updated: 2023-10-11

Locations

1 site across 1 country: China