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Trial - NCT05658523


Column Value
Trial registration number NCT05658523
Full text link
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05658523

First author
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Kim Mulholland, MD/Prof

Contact
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Kim.Mulholland@lshtm.ac.uk

Registration date
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

2022-12-20

Recruitment status
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 21, 2022, 8 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 : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

inclusion criteria: have received three doses of covid-19 vaccines at least 6 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 : Dec. 21, 2022, 8 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 : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Murdoch Childrens Research Institute

Inclusion age min
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Australia

Type of patients
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

600

primary outcome
Last imported at : Dec. 21, 2022, 8 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 : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Dec. 21, 2022, 8 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2441, "treatment_name": "Mrna-1273.214", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]