Trial record 13 of 166 for:    "Poliomyelitis"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Guangxi Center for Disease Control and Prevention
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:
NCT01510366
First received: January 6, 2012
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ 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: Inactivated Poliomyelitis Vaccine (Salk strains)
Phase 3

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 Ⅲ 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:
  • The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ] [ Designated as safety issue: No ]
    Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.

  • The observation of safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Parallel study on comparison of number of local and systemic adverse events of each vaccine after each vaccination.


Secondary Outcome Measures:
  • The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ] [ Designated as safety issue: No ]
    Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination

  • Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV [ Time Frame: 30-60 days after third dose immunization ] [ Designated as safety issue: Yes ]
    One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.


Estimated Enrollment: 1200
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Other Name: Sabin IPV
Experimental: Cohort 2:
Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.
Biological: Inactivated Poliomyelitis Vaccine (Salk strains)
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Other Name: Salk IPV or cIPV

Detailed Description:

The Sabin IPV was manufactured with poliovirus type 1, 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. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.

Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.

This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510366

Contacts
Contact: Guoyang Liao, Ph D 86-0871-8334330 liaogy@imbcams.com.cn
Contact: Yanping Li, MD 86-0771-2518985 liyanping@163.com

Locations
China, Guangxi
Pingle Center for Disease Prevention and Control Recruiting
Guilin, Guangxi, China, 530400
Contact: Tiande Zeng, MD    86-0773-7882799      
Sub-Investigator: Tiande Zeng, MD         
Bingyang Center for Disease Prevention and Control Recruiting
Nanning, Guangxi, China, 530400
Contact: Ruxin Li, MD    86-13707867181      
Sub-Investigator: Ruxin LI, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Guangxi Center for Disease Control and Prevention
National Institute for the Control of Pharmaceutical and Biological Products, China
Investigators
Principal Investigator: Guoyang Liao, PH.D Institute of Medical Biology, Chinese Academy of Medical Sciences
Principal Investigator: Yanping Li, MD Guangxi Center for Disease Prevention and Control
Principal Investigator: Changgui Li, PHD National Institute for the Control of Pharmaceutical and Biological Products, China
  More Information

Additional Information:
No publications provided

Responsible Party: Guoyang Liao, Head of Biologicals No.5, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01510366     History of Changes
Other Study ID Numbers: IMBCAMS-03, 2011L01484
Study First Received: January 6, 2012
Last Updated: January 17, 2012
Health Authority: United States: 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 11, 2014