A randomised trial to evaluate the immune response of COVID-19 vaccines in adults and adolescents

Phase 4

Recruiting

• Conditions: COVID-19; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000238774
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

To be eligible a person must:
1. Be equal to or over 12 years of age.
2 .Have received:
-two doses of BNT162b2 and be less than 70 years old OR
-two doses of ChAdOx1-S and be equal to or over 50 years old OR
-two doses of mRNA1273 and be between 12 and 18 years old.
3. Be willing to receive a COVID-19 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.

Exclusion Criteria

A person is not eligible if they:
1. Have received a COVID-19 booster vaccine in the preceding 3 months
2. Individuals who are contraindicated to receive any of the COVID-19 study vaccines. E.g. have a history of anaphylaxis to a vaccine component or myocarditis attributed to previous receipt of a messenger ribonucleic acid (mRNA) vaccine.
3. Are severely immunocompromised or have a known immunodeficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified