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

Poliomyelitis Clinical Trial

— Sabin IPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056705
• Other study ID #: imbcams-02
• Secondary ID: SFDA2007L02021
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2010
• Last updated: July 31, 2016
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
• Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
• Inactivated Poliomyelitis Vaccine (Sabin strains)
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
• Oral Poliomyelitis Vaccine
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
• Inactivated Poliomyelitis Vaccine (Salk strains).
3x0.5ml intramuscular injections, one month apart.

Locations

Country	Name	City	State
China	Pingle Center for Disease Control and Prevention	Pingle county	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
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	To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants .		one year	Yes