A clinical trial of an investigational COVID-19 vaccine for young children

Trial ID: ROVER-mRNA-1273-P306 (Part 3)

The ROVER Study is a Phase 3 clinical trial being conducted by Moderna to evaluate investigational vaccines that may protect children 6 months to 5 years of age from getting sick if they come into contact with SARS-CoV-2 (also called coronavirus), which causes COVID-19.

Trial Details

The ROVER Study has completed enrollment for Parts 1 and 2 of the trial, but are now enrolling participants in Part 3.

Part 3 of the ROVER Study has been added to understand if the dosing schedule for children could be simplified, which in turn may help to increase vaccine usage within the pediatric population.

The purpose of this clinical trial is to evaluate a booster dose of mRNA-1273.815, Moderna’s investigational COVID-19 vaccine, to learn more about whether the investigational vaccine is safe when given as a booster that is the same dose as an initial COVID-19 vaccination. An investigational vaccine is not yet approved by a country’s drug regulatory agency.

Estimated Enrollment

Approximately 300 for Part 3 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 6 months to 5 years old
Be in good health
Have completed an age-appropriate vaccination series of an authorized COVID-19 vaccine
Have parents/guardians willing and able to attend all trial visits

Participants must not:

Have received or plan to receive any vaccine 14 days before or after the trial injection
Have received the most recent authorized COVID-19 vaccination (Omicron XBB.1.5) This would typically mean they received the COVID-19 vaccination sometime after September 11, 2023

Site Locations

Participants will need to go to one of the clinics taking part in this clinical trial.

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

What to Expect

Participation in Part 3 of the ROVER Study will last approximately 7 months and includes phone calls with the trial team and 2 in-person visits to a clinical trial site. Participants will receive 1 booster injection.

All participants will receive the investigational vaccine, mRNA-1273.815.

You will be asked to use an eDiary app on your smartphone (or a provided device) to answer questions about how your child is feeling. During in-person clinical trial site visits, you and your child will answer questions about how they are feeling and complete study tests, including physical exams and blood tests.

Insurance is not required to participate, and all trial-related procedures and exams will be covered at no cost to you. Qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is COVID-19?

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and loss of speech or mobility. The World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide.

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 analyzed.

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, drug, 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, drug, 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, drug, 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 drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’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, sexes, 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.

Does the mRNA-1273.815 investigational vaccine contain a live virus?

The investigational vaccine being evaluated in this clinical trial is called mRNA-1273.815. Unlike vaccines that are made from weakened or killed viruses, mRNA-1273.815 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this investigational vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real virus that causes COVID-19, should it ever enter your body. You cannot get COVID-19 from the mRNA-1273.815 investigational vaccine.

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.

This trial is not actively recruiting.