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Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

NCT04386707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2021-08-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age

Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age

BIOLOGICAL

Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age

Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age

BIOLOGICAL

Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age

Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age

BIOLOGICAL

Three doses control wIPV at the schedule of 2,3,4 months of age

Three doses control wIPV at the schedule of 2,3,4 months of age

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yan Zheng, Master · Yunnan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2020-05-11
Completion
2020-10-20

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 NCT04386707 on ClinicalTrials.gov