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Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

NCT04264598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-02-11

No results posted yet for this study

Summary

The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18\~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60\~90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Conditions

Interventions

BIOLOGICAL

sIPV

The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.

BIOLOGICAL

Commercialized sIPV

The commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.

BIOLOGICAL

Commercialized IPV

The commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose.

Sponsors & Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Fengcai Zhu, Master · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2017-12-19
Completion
2018-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264598 on ClinicalTrials.gov