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

Poliomyelitis Clinical Trial

— IPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510366
• Other study ID #: IMBCAMS-03
• Secondary ID: 2011L01484
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2023
• Source: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 90 Days

Eligibility

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.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
• Inactivated Poliomyelitis Vaccine (Salk strains)
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.

Locations

Country	Name	City	State
China	Pingle Center for Disease Prevention and Control	Guilin	Guangxi
China	Bingyang Center for Disease Prevention and Control	Nanning	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences	Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants	Parallel study on comparison of sera protection rates (Neutralization antibody titer =1:8) of Sabin IPV and Salk IPV after three doses of vaccination.	fours year
Secondary	The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants	Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination	One year
Secondary	Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV	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.	30-60 days after third dose immunization

External Links

•   Home page of Institute of Medical Biology, Chinese Academy of Medical Sciences