A randomised trial to evaluate the immune response of COVID-19 vaccines in adults and adolescents
Platform Trial In COVID-19 Vaccine BOOsting (PICOBOO) - A single blinded, phase IV, adaptive randomised trial to evaluate the immunogenicity of COVID-19 booster vaccines in adults and adolescents
The Kids Research Institute Australia
1,325 participants
Mar 29, 2022
Interventional
Conditions
Summary
The PICOBOO study platform is designed to be an adaptive randomised trial to evaluate the safety and effectiveness of COVID-19 booster vaccine strategies in the Australian context. This will enable regulators, researchers and policymakers to flexibly respond to new policy questions as they arise, for example as new vaccine formulations become available and new variants arise in Australia necessitating changes in strategy. This study aims to evaluate, pragmatically and efficiently, the immunogenicity and reactogenicity offered by alternative booster vaccination strategies against SARS-CoV-2. This adaptive trial is designed to allow for perpetual enrolment for as long as is needed to generate high-quality data to inform Australia's national COVID-19 booster vaccination practice and policy.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants will receive a single intramuscular dose of vaccine administered by a study nurse: Arm 1: COMIRNATY JN.1 (Bretovameran), 30 µg contained in 0.3ml of undiluted vaccine suspension. Arm 2: SPIKEVAX JN.1 (SARS-COV-2 JN.1 mRNA), 50µg contained in 0.5ml of undiluted vaccine suspension. Arm 3: NUVAXOVID JN.1, 5µg of SARS-CoV spike protein adjuvanted with Matrix-M in 0.5ml of undiluted vaccine suspension.
Locations(3)
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ACTRN12622000238774