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Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

NCT04051736 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-09-09

No results posted yet for this study

Summary

This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

Conditions

  • Vaccination

Interventions

BIOLOGICAL

Inactivated Polio Vaccine

Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

Sponsors & Collaborators

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Beijing Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Peking University

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Jiang WU · Beijing Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-28
Completion
2020-08-31

Countries

  • China

Study Locations

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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 NCT04051736 on ClinicalTrials.gov