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

Institute of Medical Biology, Chinese Academy of Medical Sciences

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Treatments

Biological: Inactivated Poliomyelitis Vaccine (Salk strains)

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

Study type

Interventional

Funder types

Other

Identifiers

NCT01510366

IMBCAMS-03

2011L01484 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,200 patients

Sex

All

Ages

60 to 90 days old

Volunteers

Accepts Healthy Volunteers

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.