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).
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01056705
Ages eligible for Study
60 Days to 90 Days
Genders eligible for Study
Accepts Healthy Volunteers
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℃.
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;
All locations for NCT01056705
Pingle Center for Disease Control and Prevention
Pingle county, Guangxi, China, 542400
View full eligibility
Tris trial is registered with FDA with number: NCT01056705. The sponsor of the trial is Chinese Academy of Medical Sciences and it is looking for 500 volunteers for the current phase.
Official trial title: The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
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