Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

This research is testing a new vaccine designed to prevent severe infections caused by a type of bacteria called Escherichia coli (E. coli), specifically those that spread beyond the gut. It's also looking at a high-dose flu vaccine, which offers stronger protection against influenza. The study involves adults aged 65 and older and aims to understand how well these vaccines boost the body's defence system, how safe they are, and if they cause any side effects. An important part of the study is checking if people can receive both vaccines at the same time without issues. Researchers will measure how many protective antibodies people produce after getting the vaccines.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen Vaccines & Prevention B.V.

Enrolment target

400

Start

18 Sep 2023

Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease

What is this study about?

This study is a detailed research project focused on protecting older adults (aged 65 and above) from two important health threats: specific severe E. coli infections and the flu. E. coli is a common type of bacteria, but some strains can cause very serious infections if they spread from the gut to other parts of the body. These are known as 'extraintestinal pathogenic E. coli' infections, or ExPEC for short, and they can be particularly dangerous for older people.

The study is testing a new vaccine called ExPEC9V, which is designed to help your body fight off these specific harmful E. coli strains. It's also looking at a high-dose flu vaccine, which is a stronger version of the regular flu jab, intended to give older people better protection against influenza. Researchers are keen to find out how well these vaccines work to create a strong immune response (that is, how many protective antibodies your body makes), if they are safe to use, and what side effects they might cause. A key part of this research is also to see if these two vaccines can be given together at the same time without reducing their effectiveness or increasing side effects.

By carefully studying these vaccines, including how the body responds to them and how safe they are, especially when given together, the scientists hope to find better ways to protect older adults from these potentially serious infections. The results of studies like this help doctors make informed decisions about future vaccination programmes and improve public health.

Key takeaways

This study evaluates a new E. coli vaccine and a strong flu shot for adults aged 65 and over.
It aims to understand vaccine safety and how well they boost your immune system.
Researchers are also checking if both vaccines can be given safely together.
Participation involves injections, blood tests, and regular health checks.
The study is 'double-blind', meaning you won't know if you get the active vaccines or a dummy shot.

Who may be eligible?

To be considered for this study, you must be an adult aged 65 or older. The study is open to both men and women.

The research team will have specific health requirements to make sure it's safe for you to take part. This might include checking your overall health, any existing medical conditions you have, and any medicines you are currently taking. These checks are important to ensure your safety throughout the study.

Because this is a research study involving vaccines, there will be certain health conditions or past medical treatments that might mean you can't join. The healthcare team running the study will discuss all these details with you during a screening visit to see if this study is a good fit.

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 65 years old or older?
Are you able to attend regular appointments for checks and blood tests?
Do you feel generally well and able to participate in a study?
Are you willing to potentially receive a dummy (placebo) injection?
Are you comfortable having blood samples taken for testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive several different injections. These include the new E. coli vaccine (ExPEC9V), a high-dose flu vaccine, or a saline solution (a simple salt water solution which acts as a dummy treatment). You might receive both active vaccines, one, or the dummy shot, depending on which group you are assigned to. Nobody, including you or the study doctors, will know which treatment you are getting until the end of the study.

You would attend regular study visits over a period of time. At these visits, you'll have blood samples taken to measure your body's immune response to the vaccines (checking how many protective antibodies you've made). The research team will also carefully check for any side effects or changes in your health. You will likely be asked to keep a record of any symptoms or reactions you experience at home. The total duration of your involvement in the study will be explained in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a high-dose flu vaccine or the new E. coli vaccine, which could provide protection against these infections. However, there's no guarantee the vaccines will work for you, or that you'll receive an active vaccine. Potential risks are generally mild and similar to other vaccines, like soreness, redness, or swelling at the injection site, or feeling generally unwell for a short period. More serious side effects are rare but possible. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Poland

Common questions

What is ExPEC?

ExPEC stands for 'extraintestinal pathogenic E. coli'. It's a type of E. coli bacteria that can cause serious infections when it spreads from your gut to other parts of your body, which can be particularly risky for older adults.

What is a 'high-dose' flu vaccine?

A high-dose flu vaccine is a stronger version of the regular flu jab. It contains more active ingredients to help older people, whose immune systems might not respond as strongly to standard vaccines, build better protection against the flu.

Why are they studying these vaccines together?

Researchers want to see if it's safe and effective to give both the new E. coli vaccine and the high-dose flu vaccine at the same time. This could make it easier for people to get protected against both infections in one go.

What does 'double-blind' mean?

Double-blind means that neither you (the participant) nor the study doctors will know whether you are receiving the active vaccines or a dummy treatment (like a saline solution). This helps ensure the study results are fair and unbiased.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related treatments and tests will be provided free of charge.