The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV) (Sabin 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 (Responsible Party):
Guoyang Liao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01056705
First received: January 25, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).


Condition Intervention Phase
Poliomyelitis
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Biological: Oral Poliomyelitis Vaccine
Biological: Inactivated Poliomyelitis Vaccine (Salk strains).
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase Ⅱ 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 and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants . [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Experiment Infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Other Name: Sabin IPV
Experimental: Cohort 2: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Other Name: Sabin IPV
Experimental: Cohort 3: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Other Name: Sabin IPV
Experimental: Cohort 4: Experiment infants
Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral;
Biological: Oral Poliomyelitis Vaccine
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
Other Name: OPV
Experimental: Cohort 5: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml intramuscular injections;
Biological: Inactivated Poliomyelitis Vaccine (Salk strains).
3x0.5ml intramuscular injections, one month apart.
Other Name: Salk IPV

Detailed Description:

The Sabin IPV was manufactured with poliovirus type1, 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. 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.

Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.

This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.

  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 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;
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056705

Locations
China, Guangxi Province
Pingle Center for Disease Prevention and Control
Pingle county, Guangxi Province, China, 542400
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 by Chinese Academy of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guoyang Liao, Head of Biologicals No.5, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01056705     History of Changes
Other Study ID Numbers: imbcams-02, SFDA2007L02021
Study First Received: January 25, 2010
Last Updated: January 17, 2012
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 September 22, 2014