Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220515
• Other study ID #: 20170416
• Status: Completed
• Phase: Phase 4
• Start date: February 8, 2018
• Est. completion date: October 14, 2019

Study information

• Verified date: October 2023
• Source: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49731
• Est. completion date: October 14, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU

Locations

Country	Name	City	State
China	Disease prevention and control center of Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences	Shanghai Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety monitoring	Active and passive monitoring for local and systemic adverse reactions	30 days post inoculation