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

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

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

Study Overview

Detailed Description

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 1

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
      • He Zhou, Guangxi, China, 542800
        • Hezhou 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females, age from 60 days to 60 years old;
  • Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
  • 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;
  • Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
  • 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 ).

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: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Infants I-1
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV,lot No.20080303
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Other Names:
  • Sabin IPV, lot No.20080302
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV, lot No.20080301
EXPERIMENTAL: Infants I-2
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV,lot No.20080303
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Other Names:
  • Sabin IPV, lot No.20080302
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV, lot No.20080301
EXPERIMENTAL: Infant I-3
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV,lot No.20080303
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Other Names:
  • Sabin IPV, lot No.20080302
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other Names:
  • Sabin IPV, lot No.20080301

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time Frame: one year
one year

Collaborators and Investigators

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

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

August 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

August 1, 2008

More Information

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.

Clinical Trials on Poliomyelitis

Clinical Trials on Inactivated Poliomyelitis Vaccine (Sabin strains)

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