This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

Potentially Help Prevent Seasonal Influenza

Trial ID: mRNA-1010-P302

You have the power to advance research of an investigational vaccine that may potentially change the future of seasonal influenza with 1 injection. The Glow Trial is studying investigational vaccine mRNA-1010 to understand whether it can help protect against seasonal influenza. Seasonal influenza is a respiratory illness that more severely affects people 65 years of age and older.

How mRNA Is Powering the Glow Trial

The Glow Trial is sponsored by Moderna. Moderna is advancing messenger RNA (mRNA) science to create a new class of vaccines for patients. The purpose of this clinical trial is to assess the safety and efficacy of an investigational vaccine aimed at preventing seasonal influenza in adults over 50. An investigational vaccine is a vaccine not yet approved by a country’s drug regulatory agency.

Seasonal influenza is caused by the influenza virus. This virus infects the lungs and breathing passages and is easily spread from person to person.

Every year, seasonal influenza causes: 3 to 5 million cases of severe illness worldwide Up to 650,000 deaths worldwide

Current seasonal influenza vaccines are usually only up to 60% effective. An mRNA vaccine has the potential to offer broader protection by responding to changes in seasonal influenza strains more quickly. It also may create stronger immune responses and improve protection in older adults. That’s why Moderna is studying an mRNA-based investigational seasonal influenza vaccine to see if it is effective.

Estimated Enrollment

23,000 Participants

Phase

Who Can Take Part

Participants must:

50 years of age or older
Able to follow participation instructions
Not pregnant or planning on becoming pregnant for at least 3 months following your vaccine visit (as appropriate)

Participants must not:

Have gotten any other vaccine 28 days before or after getting the clinical trial vaccine
Have gotten a seasonal influenza vaccine in the 6 months before getting the clinical trial vaccine

Other criteria may apply in order to be eligible.

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Site Locations

The Glow Trial will be recruiting participants across 11 countries. See if there’s a clinical trial site near you by using the map below.

What to Expect

Your participation in the Glow Trial should last about 13 months.

It will include up to 3 trial visits and up to 6 phone calls to check in about any side effects
Participants will be given 1 injection in the upper arm. Each participant has a 50% chance of getting the investigational vaccine and a 50% chance of getting a currently approved seasonal influenza vaccine—like flipping a coin
Participants must provide information about their health status and whether they experience any influenza symptoms by entering information into a symptom-reporting electronic diary, or eDiary. Participants will provide information on their health status every day for the first 7 days after receiving the injection. Then for about the first 6 months, participants will report symptoms in the symptom-reporting eDiary twice a week. For the next 6 months, participants will report symptoms once a week
Enrolling in this clinical trial is completely your choice. You may stop participating in the clinical trial at any time, and you do not have to give a reason for doing so
Compensation for your trial-related time may be provided

Frequently Asked Questions (FAQs)

What is seasonal influenza?

Seasonal influenza is a respiratory illness caused by the influenza virus. This virus infects the lungs and breathing passages and is easily spread from person to person. Seasonal influenza can lead to severe illness and, in some cases, death.

Why are clinical trials important?

Clinical trials, and the participants who take part, are vital to creating vaccines. Vaccines aim to safely protect people against infection. Clinical trials like this are required for any new treatment before it can be made available to the general population.

What is a Phase 3 clinical trial?

There are usually several phases of a clinical trial, which are each designed to learn more about the investigational vaccine’s effects. In early phases—Phase 1 and 2—the clinical trial may involve few participants and is focused on evaluating safety. A Phase 3 trial is the last stage of research before a vaccine can be made available for public use after approval from a country’s drug regulatory agency. Phase 3 trials generally evaluate safety and efficacy in a large group of participants.

Why is diversity important in clinical trials?

Given that different ages, sexes, races, and ethnicities can respond differently to vaccines, it is important that this clinical trial include a group of people with many different backgrounds. A diverse group of participants helps researchers understand how different people react to the investigational vaccine and make sure that it is safe and effective for everyone.

Moderna is committed to researching safe and effective mRNA-based vaccines and therapies to bring better health and living to people of all ages, sexes, and backgrounds.

Will compensation be available?

Compensation for your trial-related time may be provided. Travel expenses related to your participation will be reimbursed. The clinical trial site will review these details with you.

Does the mRNA-1010 investigational vaccine contain a live virus?

Normally, vaccines for viruses are made from a weakened or inactive version of the virus. However, mRNA-1010 is different. The mRNA-1010 vaccine contains mRNA that is entirely made in a laboratory and instructs your body to make small pieces of proteins.

In this case, the vaccine contains the mRNA code for the hemagglutinin (HA) protein of influenza. The influenza HA protein does not cause seasonal influenza infection but may help your body’s immune system recognize the virus and protect itself if it comes in contact with the virus. You cannot become infected with seasonal influenza from getting the investigational vaccine.

What is the control?

In order to understand whether the investigational vaccine works, medical researchers are comparing it to an active control, also called an active comparator. An active control is a currently approved vaccine. In this clinical trial, it is a currently approved seasonal influenza vaccine made from an inactive influenza virus.

What if I change my mind?

Clinical trials are completely voluntary. You may stop participation in the clinical trial at any time, and you do not have to give a reason for doing so.

References

World Health Organization. Influenza (seasonal): ask the expert: influenza Q&A. Published November 6, 2018. https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
Belongia EA, Simpson MD, King JP, et al. Variable influenza vaccine effectiveness by subtype: a systematic review and meta-analysis of test-negative design studies. Lancet Infect Dis. 2016;16(8):942-951. doi:10.1016/S1473-3099(16)00129-8
Rockman S, Laurie KL, Parkes S, Wheatley A, Barr IG. New technologies for influenza vaccines. Microorganisms. 2020;8(11):1745.