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

This study has been completed.
Sponsor:
Collaborators:
Guangxi Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01048190
First received: January 12, 2010
Last updated: January 13, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Poliomyelitis
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

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

Secondary Outcome Measures:
  • To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Days to 90 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Institute of Medical Biology, 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

Additional Information:
No publications provided

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
Study First Received: January 12, 2010
Last Updated: January 13, 2010
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

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

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 15, 2014