A clinical trial for an investigational COVID-19 vaccine for infants.

Trial ID: mRNA-1273-P206

The BabyCOVE Study is a Phase 2 clinical trial conducted by Moderna to determine whether an investigational vaccine can protect infants 12–26 weeks old from COVID-19, including the Omicron variant. Over the course of the pandemic, there has been an increase in prevalence of the COVID-19 in children, leaving an urgent need for pediatric vaccinations to protect against SARS-CoV-2, the virus that causes COVID-19.

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Trial Details

The purpose of the BabyCOVE Study is to assess the safety and effectiveness of an investigational vaccine against SARS-CoV-2 in infants 12–26 weeks old.

The BabyCOVE Study will be conducted in 2 parts:

About 100 participants will be enrolled into Part 1, which will evaluate 2 different doses of the investigational vaccine, starting with the lower dose. Once the lower dose has been shown to be safe, an increased dosage will be given to new participants to determine which dose level is most effective against COVID-19.
Once the best dosage level has been determined in Part 1, Part 2 will begin. About 600 participants will be assigned at random to receive either the dose of the investigational vaccine determined in Part 1 or a placebo (a saline solution that contains no active ingredient). Participants will not know whether they receive the investigational vaccine or the placebo.

All participants will receive 2 doses, 8 weeks apart.

Estimated Enrollment

700 Participants

Phase

Phase 2

Eligibility Criteria

Participants must:

Be 8 weeks – <6 months old at the time of the screening visit
Be in good health
Have parents/guardians willing and able to attend all trial visits

Participants must not:

Have had COVID-19 or close contact with someone with COVID-19 within the past 14 days
Have received or plan to receive any vaccine 14 days before or after the first or second clinical trial vaccination

Site Locations

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

What to Expect

Participation in this clinical trial lasts up to 15 months and includes up to 8 in-person visits and up to 2 virtual visits with the clinical trial staff.

Participants will receive 2 vaccinations, approximately 8 weeks apart (Day 1 and Day 57).

At in-person visits, the clinical trial staff will perform a physical exam, sometimes including a nasal swab and blood draw.

Participants’ parents will be asked to use an eDiary app on their personal smartphone or a provided device to answer prompts and report any symptoms their child experiences.

Insurance is not needed to join this clinical trial, and compensation for trial-related time may be available.

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 a new 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?

Compensation for your trial-related time may be provided.

Does the investigational vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the investigational vaccine in this clinical trial is different. It is 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 SARS-CoV-2. You cannot get COVID-19 from the investigational vaccine.

What is a placebo?

To better know if the investigational vaccine works, researchers may compare the investigational vaccine to an inactive drug called a placebo, which can be a sugar pill or saltwater solution. A placebo looks like the investigational vaccine being tested but does not contain an active ingredient.

All participants receive the same level of quality care regardless of whether they are assigned to the investigational vaccine, or the placebo.

How can I check to see if my child is eligible for this trial?

You can check if your child is 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 my child from the trial at any time?

You have the right to end your child’s 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.