Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Optimizing the time of day of influenza vaccine administration in adults aged 60-85 years: A randomized controlled trial

This research is investigating whether the time of day you receive your flu vaccine makes a difference to how well your body protects itself against the flu. We're focusing on adults aged 60 to 85 years old. Participants will receive a flu vaccine, and some may also receive a pneumonia vaccine. We'll be checking your blood before and after the vaccination to see how strongly your immune system responds. We're also curious if the time you naturally feel most awake or sleepy (your 'chronotype') plays a role. The aim is to find out if there's an 'optimal' time to get vaccinated to boost your protection and reduce your chances of getting the flu.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Enrolment target

440

Start

15 Aug 2024

Influenza

What is this study about?

This study is all about understanding how to get the most out of your flu jab if you're aged between 60 and 85. We know that as we get older, our immune system can respond a bit differently to vaccines. This research wants to explore if giving the flu vaccine at a specific time of day could help your body build a stronger defence against the flu virus.

To do this, we'll be giving participants a standard flu vaccine. Some participants might also receive a pneumonia vaccine as part of the study. We'll then closely monitor how your immune system reacts. This involves taking blood samples before and some weeks after the vaccination to measure the level of protective antibodies your body has made. Antibodies are tiny proteins that help fight off infections.

We'll also be looking at other things, such as whether your natural body clock – meaning if you're a 'morning person' or a 'night owl' – affects how well the vaccine works. The ultimate goal is to find out if there's a particular time of day that helps people in this age group create the strongest possible protection, which could lead to better flu prevention for everyone.

Key takeaways

This study explores the best time of day for flu vaccination in older adults.
It aims to improve how well flu vaccines work for people aged 60-85.
Participants will receive a standard flu vaccine.
Blood tests are used to measure the body's immune response.
The study lasts about six months, including follow-up for flu symptoms.

Who may be eligible?

This study is looking for adults aged 18 years and above. There is no upper age limit for participants.

Both men and women are welcome to take part in this research.

While the original trial targeted individuals aged 60-85, the current eligibility criteria state '18 years to any' and 'All' for sex. This suggests that the study might be open to a wider age range and both genders. If you are interested, it's best to discuss your specific situation with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man or a woman?
Are you generally healthy enough to receive a flu vaccine?
Are you able to attend appointments for vaccine administration and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked some questions and have some checks to make sure the study is right for you. You'll then receive a flu vaccine and possibly a pneumonia vaccine. We'll carefully record details about your health and the time of your vaccination. Blood samples will be taken before the vaccination and again about 28 days later to see how your immune system has responded.

You might also be asked to answer questions about your usual sleep patterns and when you feel most awake. For the next six months, you would be asked to use simple home tests if you develop flu-like symptoms and report these back to the study team. The total time you'll be involved in the study will be around six months.

Potential risks and benefits

Taking part in this study may offer personal benefits by helping researchers understand how to make flu vaccines more effective, potentially benefiting future generations. You will receive a standard flu vaccine, which helps protect you from the flu. As with any vaccine, there's a small chance of side effects, usually mild, like a sore arm, headache, or slight fever. There's also a very small risk associated with blood tests, such as bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is the main goal of this study?

The main goal is to find out if getting the flu vaccine at a certain time of day helps adults aged 60-85 create better protection against the flu.

What is a 'chronotype'?

Your chronotype is whether you're naturally a 'morning person' or a 'night person' – when you feel most alert and sleepy.

Will I get a real flu vaccine or a dummy one?

All participants will receive a real, approved flu vaccine, and some might also get a pneumonia vaccine.

How many times will I need to visit a clinic?

You'll likely have at least two main visits: one for vaccination and initial blood tests, and another around 28 days later for follow-up blood tests.

What is the 'flu jab'?

The 'flu jab' is another common name for the influenza vaccine, which helps protect you from the flu virus.