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

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.

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



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)