Inactivated Poliomyelitis Vaccine Made From Sabin Strain

NCT04220515 | Completed Phase 4

• 1 other identifier: 20170416
• Study Type: interventional
• Target: 49,731
• Locations: 1 country
• Sites: 1

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).

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Safety monitoring

  Active and passive monitoring for local and systemic adverse reactions

  30 days post inoculation

Study Arms (1)

Inactivated Poliomyelitis Vaccine Made From Sabin Strain

EXPERIMENTAL

Primary 3-dose of sIPV and booster 1 dose of sIPV

Biological: Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Interventions

Inactivated Poliomyelitis Vaccine Made From Sabin Strain BIOLOGICAL

Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU

Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Shanghai Center for Disease Control and Prevention: collaborator

Study Sites (1)

Disease prevention and control center of Shanghai

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 33487470 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Xiaodong Sun

  Disease prevention and control center of Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: February 8, 2018
• Primary Completion: August 8, 2019
• Study Completion: October 14, 2019
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)