Moderna Inc.

This trial is not actively recruiting.

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

A clinical trial of investigational COVID-19 booster vaccines for volunteers ages 16 and older

A clinical trial conducted by Moderna is evaluating investigational booster vaccines that may protect against the COVID-19 Omicron variant and other variants.

Trial ID: mRNA-1273-P305 [EudraCT ID: 2022-000063-51]

Trial Details

The mRNA-1273-P305 clinical trial is evaluating the safety and immune response of the investigational booster vaccines that may protect against the COVID-19 Omicron variant and other variants. The investigational Omicron variant vaccines being studied are being compared to a booster dose of Moderna’s COVID-19 vaccine, SPIKEVAX, which is the vaccine that received conditional marketing authorization in the EU. All participants will receive either an investigational Omicron variant vaccine or SPIKEVAX.

With different strains of COVID-19, there is an urgent need to develop vaccination plans that will provide greater protection. A booster vaccine that protects against COVID-19 variants, including the Omicron variant, would be a crucial public health tool to help curb the pandemic.

Estimated Enrollment

4000 Participants

Phase

2/3

Eligibility Criteria

Participants must:

Be 16 years of age or older
Be in good health
Have previously received two or three doses of the COVID-19 vaccine
- Participants who have previously received a third dose must have received an mRNA vaccine (Moderna, Pfizer/BioNTech) as a third dose
- Participants who have previously received two doses may have received mRNA (Moderna, Pfizer/BioNTech) or non-mRNA (Oxford/AstraZeneca, Janssen) vaccines

Participants must not:

Have received a COVID-19 vaccine within the past 90 days
Have tested positive for COVID-19 within the past 90 days
Have had close contact within the past 14 days to someone diagnosed with COVID-19
Have participated in another trial in the past 28 days

What to Expect

Participation in this clinical trial lasts up to 13 months and includes phone calls and visits to the trial site.

Participants will be given one injection in the upper arm. Participants will either receive one of the investigational Omicron variant vaccines: mRNA-1273.529, mRNA-1273.214, or the already authorized vaccine, SPIKEVAX.
Participants will be asked to attend trial site visits including a Screening Visit, a Vaccination Visit, and approximately four to five subsequent trial site visits (Month 1, Month 3, Month 6, and Month 12). Some participants will have a visit at Day 8.
Participants will be asked to have up to four scheduled phone calls with the clinical trial doctor to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.
Participants will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms you experience.
Participants will be closely monitored by the clinical trial team if any symptoms of COVID-19 are reported at any time throughout their participation.

Insurance is not needed to join this clinical trial, and compensation for participant’s time/travel will be available.

You will need to travel to one of the study clinics taking part in this clinical trial.

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

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 the MHRA and other regulatory agencies in order to ensure patients’ and trial volunteers’ 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 analyzed.

What are the phases of clinical research?

All clinical trials of new medicines go through a series of phases to test whether they’re safe and whether they work. The medicines will usually be tested against another treatment called a control. This will either be a dummy treatment (a placebo) or a standard treatment already in use.

Phase 1 trials:

A small number of people, who may be healthy volunteers, are given the medicine.
The drug is being tested in human volunteers for the first time.
Researchers test for side effects and calculate what the right dose might be to use in treatment.
Researchers start with small doses and only increase the dose if the volunteers do not experience any side effects, or if they only experience minor side effects.

Phase 2 trials:

The new medicine is tested on a larger group of people. This is to get a better idea of its effects in the short term.

Phase 3 trials:

Carried out on medicines/vaccines that have passed phases 1 and 2.
The medicine is tested in larger groups of people and compared against an existing treatment/vaccine or a comparator/placebo to see if it’s better in practice and if it has important side effects.
Trials often last a year or more and involve several thousand patients.

Phase 4 trials:

The safety, side effects and effectiveness of the medicine continue to be studied while it’s being used in practice.
Not required for every medicine.
Only carried out on medicines that have passed all the previous stages and have been given marketing licenses – a license means the medicine is available on prescription.

Reference: https://www.nhs.uk/conditions/clinical-trials/

Why is diversity important in clinical trials?

Clinical trials and participating volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial includes participants 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?

Yes, compensation for participants’ trial-related time spent will be available. The clinical research staff will review these details with participants.

Do the investigational Omicron variant vaccines contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the investigational Omicron variant vaccines are different. They are made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the coronavirus.

Can participants get COVID-19 from the investigational vaccines being researched?

Participants cannot get infected with SARS-CoV-2 or get COVID-19 illness from the investigational Omicron variant vaccines.

What happens if a participant is diagnosed with COVID-19 while in this trial?

Each participant will be closely monitored by the trial doctor and medical staff for symptoms of COVID-19. If a participant is diagnosed with COVID-19 during the trial, the participant will be scheduled for an illness visit with the clinical trial site.

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 participants quit the trial at any time?

Participation in any clinical trial is completely voluntary. Participants have the right to drop out of the trial at any time and for any reason (and they do not need to give a reason). The clinical trial doctor or clinical research sponsor also has the right to discontinue a participant at any time for the participant’s safety or if the participant no longer meets the clinical trial requirements.