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

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

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).

Study Overview

Detailed Description

The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.

Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.

This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangxi
      • Guilin, Guangxi, China, 530400
        • Pingle Center for Disease Prevention and Control
      • Nanning, Guangxi, China, 530400
        • Bingyang Center for Disease Prevention and Control

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males and females, age from 60 days to 90 days;
  • Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
  • Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
  • Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
  • Axillary temperature ≤37℃.

Exclusion Criteria:

  • Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
  • Low platelet or bleeding disorder do not allow vaccination into the muscle;
  • Have damaged or lower immunological function;
  • Received blood, plasma or immunoglobulin treatment since birth;
  • Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
  • Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Exclusion Criteria for doses 2 and 3

  • Have serious anaphylaxis or high fever, convulsion during first dose;
  • Have any circus of Exclusion Criteria after Eligible for study;
  • Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
  • Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
  • Vaccinated with any other vaccine(except DTP);
  • Stop observation determined by investigator owing to occurring serious adverse event.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV
Experimental: Cohort 2:
Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Other Names:
  • Salk IPV or cIPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time Frame: fours year
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
fours year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time Frame: One year
Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination
One year
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
Time Frame: 30-60 days after third dose immunization
One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.
30-60 days after third dose immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yanping Li, MD, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
  • Principal Investigator: Changgui Li, PHD, National Institute for the Control of Pharmaceutical and Biological Products, China
  • Principal Investigator: Guoyang Liao, PH.D, Institute of Medical Biology, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimated)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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