A clinical trial of an investigational influenza vaccine for adults

Trial ID: mRNA-1018-P301_UK

The Odyssey 301 Trial is evaluating an investigational vaccine to understand whether it may help reduce illness caused by the pandemic flu H5N1, also known as bird flu. In this trial, researchers are aiming to understand the investigational vaccine’s safety and how well it works.

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Trial Details

Moderna is looking for individuals 18 years of age or older to take part in a clinical trial of an investigational vaccine for the pandemic flu H5N1, also known as bird flu. A pandemic flu is a global outbreak of an influenza virus that most people lack immunity to. Compared to the seasonal flu, this pandemic bird flu may spread more rapidly and cause more severe symptoms.

H5 “bird flu” is a virus that causes outbreaks in birds, particularly poultry. It has also been found in other animals such as cows. People can become infected through close contact with infected animals, their droppings, or by breathing in the virus particles in a contaminated environment. In people, symptoms have most commonly been mild and may include eye redness/irritation, fever, cough, headache, sore throat, tiredness and muscle aches. In some cases, people may develop more serious symptoms such as shortness of breath or difficulty breathing, confusion and seizures and may need care in a hospital.

The Odyssey 301 Trial is helping researchers learn more about Moderna’s investigational pandemic flu vaccine, known as mRNA-1018-H5, which may potentially help protect people from getting sick if they come into contact with the virus.

Estimated Enrolment

Approximately 4,000 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 18 years of age or older.
Be in generally good health, including well-controlled chronic medical conditions.

Participants must not:

Have received any other vaccines within 28 days before the trial injections.

Site Locations

Sites are located in the towns/cities identified with the red pin:

What to Expect

Participation in the Odyssey Trial will last about 7 months and includes up to 5 scheduled visits to a trial site and 4 scheduled safety phone calls.

In order to understand whether the investigational vaccine works and is safe, it will be compared to a placebo (a substance that looks like the investigational vaccine but does not include any active ingredients). Participants will be randomly assigned to receive 2 injections of either mRNA-1018-H5 or placebo. Neither participants nor the trial doctor will know which trial injection participants are receiving, but this can quickly be found out if necessary. All trial participants will receive the same level of quality care regardless of which investigational vaccine they receive.

You must enter whether you experience any reactions into a symptom-reporting electronic diary (eDiary) smartphone app every day for 7 days after receiving each injection.

Insurance is not needed to participate, and qualified participants will receive compensation for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analysed.

What are the phases of clinical trials?

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

In Phase 1 trials, researchers test an investigational vaccine, medicine or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the investigational vaccine, medicine or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the investigational vaccine, medicine or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the medicine or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the medicine’s risks, benefits and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, genders, races and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Qualified participants will receive payment for their trial-related time and travel.

Do the investigational vaccines contain a live virus?

The investigational vaccines being evaluated in this clinical trial are called mRNA-1018. Unlike vaccines that are made from weakened or killed viruses, the mRNA-1018 vaccines are made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make a specific protein. The hope is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real influenza virus, the virus that causes the flu. You cannot get the flu from the mRNA-1018 investigational vaccines.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I remove myself from the trial at any time?

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.