Clinical trial NCT04220515: Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Official title: Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shanghai Center for Disease Control and Prevention
First posted: 2020-01-07
Enrollment: 49731
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy infants of 2 months of age
* The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
* Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
* Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
* Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
* Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
* Axillary temperature ≤37℃

Exclusion Criteria:

* Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
* Patients with fever or acute disease.
* Have thrombocytopenia or hemorrhagic diseases
* Patients undergoing immunosuppressive therapy or immunodeficiency
* Have uncontrolled epilepsy or other progressive neurological disorders
* Other situations that the investigator consider as non-eligible

Primary outcomes:
measure: Safety monitoring
timeFrame: 30 days post inoculation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Disease prevention and control center of Shanghai
Study officials:
affiliation: Disease prevention and control center of Shanghai
name: Xiaodong Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.