Status:
COMPLETED
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Poliomyelitis
Eligibility:
All Genders
60-89 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by S...
Detailed Description
This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vac...
Eligibility Criteria
Inclusion
- Healthy infants aged 60-89 days;
- legal identity;
- Informed consent form has been signed by guardians.
Exclusion
- Vaccination history of polio vaccine;
- Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
- Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
- Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
- Receipt of blood products prior to this study;
- Receipt of other study drugs within 30 days prior to this study;
- Receipt of live attenuated vaccines within 14 days prior to this study;
- Receipt of subunit or inactivated vaccines within 7 days prior to this study;
- Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
- Axillary temperature \>37.0℃;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04386707
Start Date
May 11 2020
End Date
October 20 2020
Last Update
August 18 2021
Active Locations (4)
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1
Yanshan County Center for Disease Control and Prevention
Wenshan, Yunnan, China, 663100
2
Qiubei County Center for Disease Control and Prevention
Wenshan, Yunnan, China, 663200
3
Mile City Center for Disease Control and Prevention
Yisa, Yunnan, China, 652399
4
Gejiu County Center for Disease Control and Prevention
Yisa, Yunnan, China, 661000