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| Column | Value |
|---|---|
| Trial registration number | NCT05228730 |
|
Full text link
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 30, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Aug. 30, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
2022-02-08 |
|
Recruitment status
Last imported at : Feb. 13, 2023, 8:44 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
inclusion criteria: have completed two doses of pfizer-biontech or astrazeneca vaccines with the recommended schedule 6 months prior to the date of enrolment willing and able to give written informed consent aged 18 years or above willing to complete the follow-up requirements of the study |
|
Exclusion criteria
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
received 3 doses of covid-19 vaccine received 2 doses of covid-19 less than 6 months prior to the start of the trial received a different covid-19 vaccine not available in australia currently on immunosuppressive medication or anti-cancer chemotherapy hiv infection congenital immune deficiency syndrome has received immunoglobulin or other blood products in the 3 months prior to vaccination study staff and their relatives have a history of a severe allergic reaction to any covid-19 vaccines or have a medical exception to receiving further covid-19 vaccines cannot read or understand english |
|
Number of arms
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Murdoch Childrens Research Institute |
|
Inclusion age min
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Australia |
|
Type of patients
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Aug. 30, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
13 |
|
primary outcome
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination;Total incidence of solicited reactions (systemic and local) |
|
Notes
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "single standard dose (50mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "fractional dose (20mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single standard dose (50mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "fractional dose (20mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "standard dose will be administered on day 0 of the study", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "fractional dose (15mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "standard dose will be administered on day 0 of the study", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u00a0fractional dose (15mcg) of the intervention will be administered on day 0 of the study", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |