Status:
COMPLETED
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Poliomyelitis
Eligibility:
All Genders
60-90 years
Phase:
PHASE3
Brief Summary
The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent oral poliovi...
Detailed Description
This study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Vaccine Te...
Eligibility Criteria
Inclusion
- Healthy volunteer between 60-90 days old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
Exclusion
- Prior vaccination with Poliovirus Vaccine;
- History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
- Blood product prior to study entry;
- Any other investigational medicine(s) within 30 days prior to study entry;
- Any live attenuated vaccine within 14 days prior to study entry;
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Axillary temperature \> 37.0 °C;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2018
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03822754
Start Date
June 6 2018
End Date
December 11 2018
Last Update
January 30 2019
Active Locations (1)
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1
Guanyun Center for Disease Control and Prevention
Lianyungang, Jiangsu, China, 222200