COVID-19 Fourth Dose Study in Australia
NCT05543356 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2024-03-15
Summary
This clinical trial will be a blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a second booster dose of SARS-CoV-2 vaccines in adults enrolled over two consecutive stages. Stage 1 will commence at the time of study approval and transition to stage 2 once bivalent vaccines are approved and available in Australia.
Conditions
Interventions
- BIOLOGICAL
-
Tozinameran
A single standard dose (30mcg) will be administered on day 0 of the study.
- BIOLOGICAL
-
Elasomeran
A single standard dose (50mcg) of the intervention will be administered on day 0 of the study.
- BIOLOGICAL
-
Tozinameran
A single standard dose (30mcg) will be administered on day 0 of the study.
- BIOLOGICAL
-
Elasomeran
A single standard dose (50mcg) of the intervention will be administered on day 0 of the study.
- BIOLOGICAL
-
Bivalent Pfizer-BioNTech
A single standard dose (BNT162b2 15μg +BNT162b2 OMI 15μg) will be administered on day 0 of the study.
- BIOLOGICAL
-
Bivalent Moderna
A single standard dose (BNT162b2 15μg + BNT162b2 OMI 15μg)will be administered on day 0 of the study.
- BIOLOGICAL
-
Bivalent Pfizer-BioNTech
A single standard dose (BNT162b2 15μg + BNT162b2 OMI 15μg) will be administered on day 0 of the study.
- BIOLOGICAL
-
Bivalent Moderna
A single standard dose (BNT162b2 15μg +BNT162b2 OMI 15μg) will be administered on day 0 of the study.
Sponsors & Collaborators
-
Coalition for Epidemic Preparedness Innovations
collaborator OTHER -
The Peter Doherty Institute for Infection and Immunity
collaborator OTHER -
Murdoch Childrens Research Institute
lead OTHER
Principal Investigators
-
Kim Mulholland, MD/Prof · Murdoch Childrens Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-05-02
- Primary Completion
- 2022-07-25
- Completion
- 2022-11-30
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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