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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
ChiCTR2000039988 |
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Date of registration:
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2020-11-16 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Key monitoring of drugs for Sabin strain inactivated polio vaccine (Vero cells)
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Scientific title:
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Key monitoring of drugs for Sabin strain inactivated polio vaccine (Vero cells) |
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Date of first enrolment:
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2020-08-01 |
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Target sample size:
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Active safety monitoring:20000;Passive security monitoring:30000; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=62715 |
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Study type:
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Observational study |
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Study design:
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Sequential
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Rui Ma
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Address:
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6 Second Boxing Road, Beijing Economic and Technological Development Zone, Beijing
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Telephone:
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+86 010-60963035 |
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Email:
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gsm186@126.com |
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Affiliation:
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Beijing Institute of Biological Products Co., Ltd. |
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Name:
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Shaoying Chang
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Address:
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8 Xiaonanguan Street, Taiyuan, Shanxi, China
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Telephone:
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+86 0351-7553136 |
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Email:
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chshy007@163.com |
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Affiliation:
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Shanxi Center for Disease Control and Prevention |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Healthy infants and young children of 2 months old;
2. The subject's legal guardian signs the informed consent form and signs the date;
3. The subject's legal guardian can participate in all planned follow-ups (e.g. complete the diary card and return to participate in the visit);
4. Those who were judged to be healthy according to medical history, physical examination and clinical examination, and whose axillary body temperature was <= 37.0 degrees C.
Exclusion criteria: 1. Have a history of poliomyelitis ;
2. People with a history of dystocia, suffocation rescue, neurological damage;
3. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
4. Have a history of epilepsy, convulsions, or convulsions, or have a family history of mental illness;
5. Those who have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
6. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
7. No spleen and spleen function defects caused by any situation;
8. Known or suspected diseases include: severe respiratory disease, severe cardiovascular disease, liver and kidney disease, skin disease, malignant tumor; in the acute attack of chronic disease;
9. A history of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy);
10. Have a history of severe allergic reactions to vaccination;
11. Those who are allergic to any component of the surveillance vaccine;
12. Have received live attenuated vaccine within 14 days; have received other vaccines within 7 days;
13. Are or plan to participate in other clinical trials in the near future;
14. The investigator judges other situations that are not suitable for participating in this clinical trial.
Age minimum:
2??
Age maximum:
2??
Gender:
Both
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Health Condition(s) or Problem(s) studied
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poliomyelitis
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Intervention(s)
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Active safety monitoring:Non intervention;Passive security monitoring:Non intervention;
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Primary Outcome(s)
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Incidence of adverse reactions / events;Incidence of adverse reactions / events;Incidence of severe adverse events (SAE);
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Source(s) of Monetary Support
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Self financing
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Ethics review
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Status: Approved
Approval date: 10/09/2020
Contact:
Xiahong Zhang
+86 15235176804
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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