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

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ClinicalTrials.gov Identifier: NCT01048190
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : January 14, 2010
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study Start Date : August 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009


Arms and Interventions

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;
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.
Other Name: Sabin IPV,lot No.20080303
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;
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;
Other Name: Sabin IPV, lot No.20080302
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.
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.
Other Name: Sabin IPV, lot No.20080301


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048190


Locations
China, Guangxi
Hezhou Center for Disease Prevention and Control
He Zhou, Guangxi, China, 542800
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Guangxi Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Investigators
Principal Investigator: Liao Guoyang, PhD Chinese Academy of Medical Sciences
Principal Investigator: Li Rongcheng, MD Guangxi Center for Disease Prevention and Control
Principal Investigator: Li Changgui, PhD National Institute for the Control of Pharmaceutical and Biological Products, China
More Information

Responsible Party: Liao Guoyang, PhD, Institute of Medical Biology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01048190     History of Changes
Other Study ID Numbers: imbcams-01
SFDA2007L02021 ( Other Identifier: China state food and drug adminstration )
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: August 2008

Keywords provided by Chinese Academy of Medical Sciences:
Inactivated Poliomyelitis Vaccine
Sabin Strains
poliomyelitis

Additional relevant MeSH terms:
Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs