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| Column | Value |
|---|---|
| Trial registration number | NCT05079152 |
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Full text link
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
2021-10-15 |
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Recruitment status
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - ≥18 years old when enrolled; - participants signing the informed consent; - being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview; - having not been administered any pneumonia vaccine or covid-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment; - ≥14 days from the most recent vaccination; - before enrollment, the body temperature is ≤37.0c as confirmed by medical history and clinical examination. |
|
Exclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
- having a history of covid-19 or a positive nucleic acid test for covid-19; - having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness; - being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine; - having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or hiv, or having a family member with close contact who suffers from congenital immune disorder; - having injection of non-specific immunoglobulin within 1 month prior to enrollment; - having acute febrile illness or communicable disease; - having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection; - having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes; - having various infectious, pyogenic, or allergic skin diseases; - women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination; - having any condition that may affect trial assessment as determined by researchers. exclusion criteria for the second dose: - having any serious adverse event related to the first dose vaccination; - after vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers; - having a newly emerging condition that meets the exclusion criteria for the first dose; - having any condition that may affect trial assessment as determined by researchers. |
|
Number of arms
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
China National Biotec Group Company Limited |
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Inclusion age min
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
1404 |
|
primary outcome
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Hemmagglution inhibition antibody level (IIV4);Hemmagglution inhibition antibody level (IIV4);Hemmagglution inhibition antibody level (IIV4);Neutralizing antibody level (COVAX);Neutralizing antibody level (COVAX);Neutralizing antibody level (COVAX);Neutralizing antibody level (PPV23);Neutralizing antibody level (PPV23);Neutralizing antibody level (PPV23);Seroconversion rate (COVAX);Seroconversion rate (COVAX);Seroconversion rate (IIV4);Seroconversion rate (IIV4);Seroconversion rate (PPV23);Seroconversion rate (PPV23);Seropositive rate (IIV4) |
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Notes
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Bbibp-corv+Pneumococcal vaccine, 1 ,day 0, Bbibp-corv+Iiv4, 1, day 28", "treatment_id": 1992, "treatment_name": "Bbibp-corv+flu vaccine+pneumococcal vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "2;days0-28", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pneumococcal vaccine, 1 ,day 0, flu vaccine, 1, day 28", "treatment_id": 1993, "treatment_name": "Flu vaccine+pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |