Status:
UNKNOWN
Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine
Lead Sponsor:
Zhejiang Provincial Center for Disease Control and Prevention
Conditions:
Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has la...
Eligibility Criteria
Inclusion
- Volunteers aged 18 and above at the time of screening;
- Obtain the informed consent of the volunteers and sign the informed consent;
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;
- Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.
Exclusion
- Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;
- Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma;
- Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;
- 5\) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature \> 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
Key Trial Info
Start Date :
May 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05373030
Start Date
May 14 2022
End Date
June 30 2023
Last Update
May 13 2022
Active Locations (1)
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1
Xihu District Center for Disease Control and Prevention
Hangzhou, Zhejiang, China, 310000