COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12622000238774.aspx

Peter Richmond

peter.richmond@uwa.edu.au

2022-02-10

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

To be eligible a person must: 1. Be equal to or over 18 years of age. 2. Have received two doses of Pfizer Comirnaty (Pf) or two doses of COVID-19 Vaccine Astra Zeneca (AZ). 3. Be eligible and willing to receive a COVID-19 booster vaccine authorised for use (including emergency use authorisation) by the TGA or equivalent regulatory authority. 4. Be registered on the Australian Immunisation Register (AIR), or otherwise possess evidence of primary vaccination. 5. Be willing to comply with trial requirements, including the provision of blood and saliva samples at the indicated time intervals.

A person is not eligible if they: 1. Are contraindicated to receive any study COVID-19 booster vaccine per Australian guidelines. E.g. have a history of anaphylaxis to a vaccine component or myocarditis attributed to previous receipt of a messenger ribonucleic acid (mRNA) vaccine. 2. Are immunocompromised or have known immunodeficiency.

2

Telethon Kids Institute

18

100

Australia

Healthy volunteers

N/A

800

Serum concentrations of SARS-CoV-2 anti-spike Immunoglobulin (IgG) [Day 28 after randomisation]

Phase 4

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]