MedTrace Logo

Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

NCT04224519 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-10-11

No results posted yet for this study

Summary

A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

sIPV batch 1

Type I 30 DU, Type II 32 DU, Type III 45 DU

BIOLOGICAL

sIPV batch 2

Type I 30 DU, Type II 32 DU, Type III 45 DU

BIOLOGICAL

sIPV batch 3

Type I 30 DU, Type II 32 DU, Type III 45 DU

Sponsors & Collaborators

  • Yunnan Center for Disease Control and Prevention

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Xiaoqiang Liu · Disease prevention and control center of Yunnan province

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2019-02-25
Completion
2019-10-12

Countries

  • China

Study Locations

More Related Trials

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 NCT04224519 on ClinicalTrials.gov