Status:
COMPLETED
Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector)
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
CanSino Biologics Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant SARS-CoV-2 vaccine (adenovirus type 5 vector) i...
Eligibility Criteria
Inclusion
- Health subjects aged 18-59 years, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months.
- The subject can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
- Axillary temperature ≤ 37.0℃.
- Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization.
Exclusion
- have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
- women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
- have acute febrile diseases and infectious diseases.
- have severe chronic diseases or condition in progress cannot be controlled.
- congenital or acquired angioedema / neuroedema
- have the history of urticaria 1 year before receiving the investigational vaccine.
- have asplenia or functional asplenia.
- have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
- have needle sickness.
- have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
- have received blood products within 4 months before injection of investigational vaccines.
- under anti-tuberculosis treatment.
- not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04892459
Start Date
May 25 2021
End Date
December 25 2021
Last Update
March 31 2022
Active Locations (1)
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1
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009