Evaulating the effect on immune responses of administering COVID-19 and influenza vaccines in the same or opposite arms on the same day in healthy participants: the Cannon Study

niversity of Melbourne0 sites56 target enrollmentApril 10, 2024

Overview

No summary available.

Registry

who.int

Start Date

April 10, 2024

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Melbourne

•Healthy with no significant immunosuppressive illnesses. These include but are not limited to:
•\- cancer or treatment of cancer or organ transplantation
•\- treatment of auto\-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease
•\- use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications
•\- significant renal or liver disease
•Two or more prior doses of a COVID\-19 vaccine, the last dose at least 4 months prior to recruitment
•No previous significant adverse events to prior Influenza or COVID\-19 vaccines, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature \>40\.0°C or \>10\.0 cm in diameter for redness and swelling at the site of injection
•\- severe systemic events (fatigue, headache, fever, muscle or joint pain)
•\- severe local events (pain at injection site, redness and swelling
•\- any event requiring emergency department visit or hospitalisation

•Prior COVID\-19 infection or Influenza infection within 4 months of recruitment
•Prior COVID\-19 vaccination or Influenza vaccination within 4 months of recruitment
•Pregnant or breastfeeding women and women planning to become pregnant
•Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after)
•Receiving medication that might reduce immune responses. These include but are not limited to:
•\- systemic corticosteroids
•\- interleukins
•\- interferons
•\- cyclosporine
•\- systemic chemotherapy