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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome: The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: fours year ]

Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.


Original Primary Outcome:

  • To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ]
    Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
  • To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ]
    Parallel study on comparison of number of local and systemic adverse events of each vaccine after each vaccination.


Current Secondary Outcome:

  • The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ]
    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 ]
    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.


Original Secondary Outcome:

  • To evaluate the efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants [ Time Frame: One year ]
    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 ]
    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.


Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: January 6, 2012
Date Started: January 2012
Date Completion:
Last Updated: September 13, 2015
Last Verified: September 2015