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

NCT01056705 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-08-02

No results posted yet for this study

Summary

Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ 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) formulation A. 3x0.5ml intramuscular injections,one month apart.

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.

BIOLOGICAL

Oral Poliomyelitis Vaccine

Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Salk strains).

3x0.5ml 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

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Liao Guoyang, PHD · Institute of Medical Biology, Chinese Academy of Medical Sciences

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

  • Li Changgui, 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
2009-07-31
Primary Completion
2010-05-31
Completion
2010-08-31

Countries

  • China

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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 NCT01056705 on ClinicalTrials.gov