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Key monitoring of drugs for Sabin strain inactivated polio vaccine (Vero cells)

Key monitoring of drugs for Sabin strain inactivated polio vaccine (Vero cells)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039988
Enrollment
Unknown
Registered
2020-11-16
Start date
2020-08-01
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

poliomyelitis

Interventions

Active safety monitoring:Non intervention
Passive security monitoring:Non intervention

Sponsors

Center for Disease Control and Prevention, Shanxi Provincial
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions / events;Incidence of adverse reactions / events;Incidence of severe adverse events (SAE);

Countries

China

Contacts

Public ContactShaoying Chang

Shanxi Center for Disease Control and Prevention

chshy007@163.com+86 0351-7553136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026