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| Column | Value |
|---|---|
| Trial registration number | NCT05442684 |
|
Full text link
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
2022-07-05 |
|
Recruitment status
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
inclusion criteria: participants aged 18 years and above at the time of screening. received the 1st booster vaccination at least 180 days earlier. agree to attend all visits and sign the written informed consent form. |
|
Exclusion criteria
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
have a history of seizures, epilepsy, encephalopathy, psychosis. history of severe anaphylaxis or allergy to any vaccine component. positive urine pregnancy test result, pregnant, lactating women. medical history of guillain-barré syndrome. have had asthma attacks within 2 years. have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc. bleeding disorder (e.g. protein s or factor deficiency, coagulopathy or platelet disorder). have chronic systematic infection or chronic obstructive pulmonary disease (copd), etc. administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate. current diagnosis or receiving treatment for tuberculosis or cancer. history of sars-cov-2 infection for less than 3 months. received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination. have an axillary temperature of > 37.0℃. any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data. |
|
Number of arms
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
CanSino Biologics Inc. |
|
Inclusion age min
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
None |
|
Type of patients
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 19, 2023, noon Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose. |
|
Notes
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 7, 2022, midnight Source : ClinicalTrials.gov |
[{"arm_notes": "Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation", "treatment_id": 2066, "treatment_name": "Ad5-ncov-ih", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |