Adjuvanted and standard influenza vaccines: an evaluation of their immunogenicity in healthy younger adults (The ADJUSTIVE Study)
The University of Melbourne
66 participants
Apr 13, 2026
Interventional
Conditions
Summary
This study is a randomised open-label trial of adminstering either Flucelvax (standard) and Fluad (adjuvanted) influenza vaccines. We will enrol healthy participants aged 18-50 years who did not receive any influenza vaccine in the 15 months preceding study entry and who would like to receive a 2026 influenza vaccine. We will randomise participants to receive either Flucelvax or Fluad Influenza vaccines and have blood, saliva and nasal fluid tests to follow their immune responses to the vaccines. Participants have study visits just prior to vaccination and on days 6, 28 and 180 post-vaccination. We are testing the idea that younger people who receive an adjuvanted influenza vaccine may have stronger immune reponses against a larger range of influenza virus strains
Eligibility
Inclusion Criteria14
- Aged 18-50 years
- 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
- No previous significant adverse events to prior Influenza 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
- No prior anaphylaxis to any cause, including to prior Influenza vaccines
- Willing and available to have blood, saliva and nasal fluid samples taken per the schedule of events
- Willing to be randomly assigned to receive either Afluria Quad (standard) or Fluad (adjuvanted) influenza vaccine
- Willing to provide a signed and dated informed consent form.
Exclusion Criteria8
- Receipt of any influenza vaccine in the 15 months preceding study entry
- Pregnant or breastfeeding women and women planning to become pregnant
- Receiving medication that might reduce immune responses. These include but are not limited to:
- systemic corticosteroids
- interleukins
- interferons
- cyclosporine
- systemic chemotherapy
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Fluad (adjuvanted) influenza vaccine Participants will be randomised to receive either a Flucelvax or Fluad influenza vaccine at study entry, Fluad is adminstered as a 0.5ml single dose, as an intramuscular injection. The vaccine is administered by study medical staff.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12626000334303