Status:
COMPLETED
Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- healthy participants aged 18 years and above who have not received COVID-19 vaccine.
- The subjects can provide with informed consent and sign informed consent form (ICF).
- 4\. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
- 5\. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure.
- 10\. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.
- Exclusion criteria:
- Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
- Suffering from acute febrile disease, infectious disease, or SARS infection history
- Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg)
- Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on.
- Congenital or acquired angioedema / neuroedema.
- had urticaria one year before this vaccination.
- Asplenia or functional asplenia.
- Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
- Faintng during acupuncture treatment
- Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
- Received blood products within 4 months before vaccination.
- Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
- Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
- Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
- Be receiving anti-tuberculosis treatment
- Have the history of SARS-CoV-2 infection or COVID-19
- Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT05313646
Start Date
March 8 2021
End Date
September 8 2021
Last Update
April 6 2022
Active Locations (1)
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1
Guanyun Center for Disease Control and Prevention
Lianyungang, Jiangsu, China, 222000