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Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
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).
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Disease prevention and control center of Shanghai
Shanghai, China
Start Date
February 8, 2018
Primary Completion Date
August 8, 2019
Completion Date
October 14, 2019
Last Updated
October 11, 2023
49,731
ACTUAL participants
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
BIOLOGICAL
Lead Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
NCT05644184
NCT06947499
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06137664