MedTrace Logo

The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

NCT01510366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-10-11

No results posted yet for this study

Summary

Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Salk strains)

Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.

Sponsors & Collaborators

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • National Institute for the Control of Pharmaceutical and Biological Products, China

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Guoyang Liao, PH.D · Institute of Medical Biology, Chinese Academy of Medical Sciences

  • Yanping Li, MD · Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

  • Changgui Li, PHD · National Institute for the Control of Pharmaceutical and Biological Products, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT01510366 on ClinicalTrials.gov