v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05132855 |
|
Full text link
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
chchiu@cgmh.org.tw |
|
Registration date
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
2021-11-24 |
|
Recruitment status
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
inclusion criteria: participant is willing to give written informed consent for participation in the trial. participants should receive 2 doses of the azd1222. evidence of this will be gathered from medical history and/or medical records including the covid-19 vaccine registration yellow card. |
|
Exclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
the participant may not enter the trial if any of the following apply: fever or evidence of upper respiratory tract infections confirmed covid-19 cases (pcr-confirmed infection or detectable anti-nucleocapsid protein igg) history of anaphylaxis, severe allergic disease, or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine). malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrollment. bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. has received vaccines other than covid-19 vaccine within one month pregnancy or willingness/intention to become pregnant within 3 months post booster vaccine aged < 20 years or unable to sign the informed consent any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data or insufficient level of language to undertake all study requirements in the opinion of the investigators. |
|
Number of arms
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Chang Gung Memorial Hospital |
|
Inclusion age min
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
20 |
|
Inclusion age max
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Taiwan |
|
Type of patients
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
340 |
|
primary outcome
Last imported at : July 26, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
The immune response after heterologous boost fourth dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination;The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination;The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination;The immune response of breakthrough infection after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination |
|
Notes
Last imported at : Nov. 25, 2021, 9 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "30\u00b5g, 1, day 0, IM, prior received 2 doses of the AZD1222", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "50\u00b5g, 1, day 0, IM, prior received 2 doses of the AZD1222", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100\u00b5g, 1, day 0, IM, prior received 2 doses of the AZD1222", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "15\u00b5g, 1, day 0, IM, prior received 2 doses of the AZD1222", "treatment_id": 840, "treatment_name": "Mvc-cov1901", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |