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 | NCT05543356 |
|
Full text link
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
2022-09-16 |
|
Recruitment status
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Sept. 18, 2022, 3 a.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 : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
inclusion criteria: have completed a primary schedule of two doses of pfizer-biontech or astrazeneca vaccines and received a booster of pfizer-biontech vaccine (30µg) at least 3 months earlier. no confirmed sars-cov-2 infection on pcr or rat within the last 3 months. 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 : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
currently receiving immunosuppressive medication or anti-cancer chemotherapy. known hiv infection. congenital immune deficiency syndrome. received immunoglobulin or other blood products in the three months prior to potential study booster vaccination. study staff and their relatives. have a history of a severe allergic reaction to any covid-19 vaccines or have a medical exemption to receiving further covid-19 vaccines. cannot read or understand english. |
|
Number of arms
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Murdoch Childrens Research Institute |
|
Inclusion age min
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Australia |
|
Type of patients
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Sept. 18, 2022, 3 a.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 : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Sept. 18, 2022, 3 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "received Pfizer-BioNTech(BNT162b2) as primary series and Pfizer-BioNTech(BNT162b2) as first booster", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "received Pfizer-BioNTech(BNT162b2) as primary series and Pfizer-BioNTech(BNT162b2) as first booster", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "received AstraZeneca (ChAdOx1, or Vaxzevria\u00ae) as primary series and Pfizer-BioNTech (BNT162b2) as first booster", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "received AstraZeneca (ChAdOx1, or Vaxzevria\u00ae) as primary series and Pfizer-BioNTech (BNT162b2) as first booster", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " received Pfizer-BioNTech(BNT162b2) as primary series and Pfizer-BioNTech(BNT162b2) as first booster", "treatment_id": 2529, "treatment_name": "Bnt162b2+bnt162b2.b.1.351", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " received Pfizer-BioNTech(BNT162b2) as primary series and Pfizer-BioNTech(BNT162b2) as first booster", "treatment_id": 2441, "treatment_name": "Mrna-1273.214", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "eceived AstraZeneca (ChAdOx1-S, or Vaxzevria\u00ae) as primary series and Pfizer-BioNTech (BNT162b2) as first booster", "treatment_id": 2527, "treatment_name": "Bnt162b2 (b.1.1.529)+bnt162b2.b.1.351", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "eceived AstraZeneca (ChAdOx1-S, or Vaxzevria\u00ae) as primary series and Pfizer-BioNTech (BNT162b2) as first booster", "treatment_id": 2441, "treatment_name": "Mrna-1273.214", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |