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

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis

Eligibility Criteria

60 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

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 ).

Sites / Locations

  • Hezhou Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Infants I-1

Infants I-2

Infant I-3

Arm Description

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

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

Outcomes

Primary Outcome Measures

To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Secondary Outcome Measures

To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Full Information

First Posted
January 12, 2010
Last Updated
January 13, 2010
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, National Institute for the Control of Pharmaceutical and Biological Products, China
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1. Study Identification

Unique Protocol Identification Number
NCT01048190
Brief Title
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Acronym
IPV
Official Title
The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, National Institute for the Control of Pharmaceutical and Biological Products, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infants I-1
Arm Type
Experimental
Arm Description
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;
Arm Title
Infants I-2
Arm Type
Experimental
Arm Description
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Arm Title
Infant I-3
Arm Type
Experimental
Arm Description
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Other Intervention Name(s)
Sabin IPV,lot No.20080303
Intervention Description
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Other Intervention Name(s)
Sabin IPV, lot No.20080302
Intervention Description
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis Vaccine (Sabin strains)
Other Intervention Name(s)
Sabin IPV, lot No.20080301
Intervention Description
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Primary Outcome Measure Information:
Title
To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao Guoyang, PhD
Organizational Affiliation
Institute of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Rongcheng, MD
Organizational Affiliation
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Changgui, PhD
Organizational Affiliation
National Institute for the Control of Pharmaceutical and Biological Products, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hezhou Center for Disease Prevention and Control
City
He Zhou
State/Province
Guangxi
ZIP/Postal Code
542800
Country
China

12. IPD Sharing Statement

Links:
URL
http://imbcams.ac.cn/Index.html
Description
Home page of Institute of Medical Biology, Chinese Academy of Medical Sciences

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

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