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