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Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)

NCT04264546 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-11

No results posted yet for this study

Summary

The purpose of this phase Ib 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 high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, 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 investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Sponsors & Collaborators

  • 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
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2018-03-09
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 NCT04264546 on ClinicalTrials.gov