Clinical trial NCT01510366: The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
Official title: The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Keywords: Inactivated Poliomyelitis Vaccine
Sabin Strains
poliomyelitis
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guangxi Center for Disease Control and Prevention
name: National Institute for the Control of Pharmaceutical and Biological Products, China
First posted: 2012-01-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 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.

Primary outcomes:
measure: The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
timeFrame: fours year
Secondary outcomes:
measure: The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
timeFrame: One year
measure: Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
timeFrame: 30-60 days after third dose immunization
Other outcomes:
Locations:
city: Guilin
country: China
facility: Pingle Center for Disease Prevention and Control
state: Guangxi
city: Nanning
country: China
facility: Bingyang Center for Disease Prevention and Control
state: Guangxi
Study officials:
affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences
name: Guoyang Liao, PH.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
name: Yanping Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for the Control of Pharmaceutical and Biological Products, China
name: Changgui Li, PHD
role: PRINCIPAL_INVESTIGATOR
References: