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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 children

Trial ID: ROVER-mRNA-1273-P306
The ROVER Study is a Phase 3 clinical trial conducted by Moderna to determine whether an investigational vaccine, mRNA-1273.214, can protect children 6 months–5 years of age from COVID-19, including the Omicron variant. Over the course of the pandemic, there has been an increase in prevalence of COVID-19 in children, creating an urgent need for pediatric vaccinations to protect against SARS-CoV-2, the virus that causes COVID-19 and its variants.

Trial Details

The purpose of the ROVER Study is to assess the safety and effectiveness of an investigational vaccine, mRNA-1273.214, against SARS-CoV-2 in children 6 months–5 years of age. About 480 participants will be enrolled into Part 1 of the ROVER Study, which will evaluate a 2-dose primary series (not booster doses) of the investigational vaccine in children who have never previously been vaccinated against COVID-19. The 2 doses will be given approximately 28 days apart.

Estimated Enrollment

480 Participants



Eligibility Criteria

Participants must:

  • Be 6 months – 5 years 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 ever been vaccinated against COVID-19
  • Have received or plan to receive any vaccine 14 days before or after the first or second trial injection

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 14 months and includes up to 6 in-person visits and up to 2 virtual visits with the clinical trial staff. Participants will receive 2 vaccinations, approximately 28 days apart. During in-person clinical study site visits, you and your child will answer questions about how they are feeling and complete study tests, including physical exams and blood tests. If your child is not feeling well and cannot make it to their site visit, the study team may come to your home instead. 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)