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

NCT01048190 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2010-01-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Sponsors & Collaborators

  • Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    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
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

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 NCT01048190 on ClinicalTrials.gov