The COVID-19 pandemic is like nothing we’ve seen in more than a century and it has altered each and every one of our lives. Now, you or your child could be a part of important research on an investigational COVID-19 vaccine.
By enrolling in the NextCOVE Study, you or your child will be contributing to a potential solution to the evolving COVID-19 pandemic, which has affected the entire world.
About Vaccine Studies
It is very important to remember these things if you are thinking about joining a vaccine trial:
The trial vaccine is investigational and has not yet been
approved for use in adults or children. This means we are still researching the product and we do not know if it is effective and safe to use. We do not know if it will prevent SARS-CoV-2 infection or reduce the severity of COVID-19 illness.
All vaccines may have some side effects and this is true for this investigational vaccine too.
In other trials of individuals receiving investigational vaccines similar to mRNA-1283.222, the most common side effects were fever, headache, muscle aches or pain, joint aches or pain, tiredness, nausea/vomiting and chills. These side effects have been more commonly reported after the later injections of the investigational vaccine and typically last between 2 and 3 days.
Throughout the trial, we will be closely monitoring participants for any side effects.
Thank you for considering
Diseases do not discriminate – and neither should medical trials.
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.
About the NextCOVE Study
The purpose of the NextCOVE Study is to evaluate an investigational bivalent vaccine that may protect people from getting sick if they come into contact with the virus that causes COVID-19 and multiple variants, including the Omicron variant.
You or your child will be chosen at random to receive either the investigational booster dose of mRNA-1283.222 or mRNA-1273.222.
In order to join this medical trial, you or your child must:
Be at least 12 years old
Have received a COVID-19 vaccine and at least 1 booster dose of a COVID-19 vaccine
The booster doses are not required for participants younger than 18 years of age. All trial participants will receive medical care from the trial doctor while in the NextCOVE Study.
The trial doctor and trial team will talk to you about additional medical support that you or your child will receive if any COVID-19 symptoms are experienced at any time while in the trial.
Insurance is not needed for you to join this medical research trial. Compensation may be provided for your time.
About the Investigational Vaccine
The NextCOVE Study is testing mRNA-1283.222, one of Moderna’s bivalent (addressing multiple viral strains at the same time) COVID-19 investigational vaccines that may protect people from getting sick if they come into contact with the virus that causes COVID-19 and multiple variants, including the Omicron variant. Moderna will be evaluating this investigational vaccine as a booster dose in children and adults to learn more about how it works in the body.
Normally, vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1283.222 investigational vaccine is different. It is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make protein. The goal of this vaccine is for the protein to trigger the body’s immune system to create the antibodies it needs to fight the real SARS-CoV-2 virus, which causes COVID-19.
You or your child, along with up to 8471 other individuals, will be helping researchers learn more about Moderna’s investigational vaccine that may help protect people from getting sick if they come into contact with the virus that causes COVID-19, including
its Omicron variant. You or your child’s participation could contribute to a potential solution to the evolving COVID-19 pandemic, which has affected the entire world.
Thank You for Your Interest in the
We understand that any decision regarding your or your child’s
health is important. By taking part in this trial, you or your child
could make a difference for your family, your community, and
Withdrawing from the NextCOVE Study
Trial participants have the right to drop out of the trial at any
time and for any reason. The trial doctor also has the right to
discontinue a trial participant at any time for the participant’s
safety or if the participant no longer meets the trial requirements.