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

Conditions

None listed

Brief 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.

J. Ramsay, Mark Jones, Ann Marie Vande More, Sharon Hunt, Phoebe Williams et al. (12 authors)

Vaccine2023-10-297 citations

10.1016/j.vaccine.2023.10.050

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,

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Be aged 18 years old or over 2. Have received within 6 hours, or must be eligible, willing and scheduled to receive, a COVID-19 vaccine on the day of enrolment 3. Be eligible and willing for seasonal influenza vaccine in accordance with the Australian Immunisation Handbook 4. Provide informed consent

Exclusion criteria

1. Unwilling or unable to adhere to follow-up (including electronic completion of 7-day diary card) 2. Contra-indicated to receive seasonal influenza vaccine 3. Previously received a COVID-19 vaccine not licensed in Australia 4. Immunocompromised individuals receiving supplementary primary COVID-19 vaccine doses due to high risk of primary vaccine failure 5. Receipt of seasonal influenza vaccine within the preceding 6 months

Outcome results