SuspendedPhase 4ACTRN12621001063808

A randomised control trial to evaluate the reactions of co-administration of influenza and COVID-19 vaccines

The FLU-VID study: A single blinded, phase IV, adaptive randomised control trial to evaluate the safety of co-administration of seasonal influenza and COVID-19 vaccines in adults

Sponsor

Sydney Local Health District

Enrollment

1,000 participants

Start Date

Nov 2, 2021

Study Type

Interventional

Conditions

COVID-19 Influenza

Summary

This study will aim to evaluate, pragmatically and efficiently, the safety (reactogenicity) of seasonal influenza vaccines co-administered with licenced COVID-19 vaccines in Australia. Simultaneous administration of vaccines is common practice within vaccine programs for children and adults worldwide. Co-administration of COVID-19 vaccines with seasonal influenza vaccines could offer significant advantages for health systems planning (including cost, administrative practicalities and effective use of resources) and for increasing the uptake of both vaccines. These benefits may be substantial given the likely need for booster doses of COVID-19 vaccines. It is envisioned that this study will be extended to assess the safety and immunogenicity of other potentially co-administered vaccines.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

Be aged 18 years old or over
Have received within 6 hours, or must be eligible, willing and scheduled to receive, a COVID-19 vaccine on the day of enrolment
Be eligible and willing for seasonal influenza vaccine in accordance with the Australian Immunisation Handbook
Provide informed consent

Exclusion Criteria5

Unwilling or unable to adhere to follow-up (including electronic completion of 7-day diary card)
Contra-indicated to receive seasonal influenza vaccine
Previously received a COVID-19 vaccine not licensed in Australia
Immunocompromised individuals receiving supplementary primary COVID-19 vaccine doses due to high risk of primary vaccine failure
Receipt of seasonal influenza vaccine within the preceding 6 months

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Interventions

Participants will receive a single dose of 0.5 mL intramuscular dose of a licensed seasonal influenza vaccine either inactivated, surface antigen, adjuvanted quadrivalent (containing 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL dose) or inactivated, surface antigen, tetravalent (containing 60 µg HA per 0.5 mL dose)) within 6 hours of vaccination with a COVID-19 vaccine (visit 1) either ChAdOx1-S (recombinant) or BNT162b2 mRNA vaccine (nucleoside-modified) or mRNA1273 vaccine or NVXCoV2373, 5µg of SARS-CoV spike protein adjuvanted with Matrix-M (visit 1) and a single dose of a placebo vaccine (0.5 mL of 0.9% saline for injection administered intramuscularly) 7-14 days later (visit 2).