Status:
COMPLETED
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Guangxi Center for Disease Control and Prevention
National Institute for the Control of Pharmaceutical and Biological Products, China
Conditions:
Poliomyelitis
Eligibility:
All Genders
60-90 years
Phase:
PHASE3
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 Va...
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, purif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01510366
Start Date
January 1 2012
End Date
September 1 2015
Last Update
October 11 2023
Active Locations (2)
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1
Pingle Center for Disease Prevention and Control
Guilin, Guangxi, China, 530400
2
Bingyang Center for Disease Prevention and Control
Nanning, Guangxi, China, 530400