A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months. Sponsor Protocol No. mRNA-1273-P206 (BabyCOVE)
Please see Original Protocol 17Jun2022, Section 3, pages 42-45 for study objectives and endpoints.
The BabyCOVE Study is evaluating an investigational bivalent vaccine. The investigational vaccine cannot make someone sick with COVID-19 and is not a gene therapy, which means it does not cross the nucleus of a cell to integrate with the host genome. The total duration of participation is approximately 15 months and, depending on a participant’s enrollment assignment, 3 brief phone calls, 2 telemedicine visits, and up to 8 clinic visits. All participants will receive 2 injections 8 weeks apart. Those enrolled in Part 1 of the study will receive the investigational pediatric vaccine, and those enrolled in Part 2 of the study will receive either the investigational pediatric vaccine or a placebo. Participants will be closely monitored by the study team if any symptoms of COVID-19 are reported at any time throughout their participation.
MoreChild
In order to enroll in the BabyCOVE Study, an individual must: -Be between 12 weeks and less than 6 months of age and in good health (some health issues are allowed if they are well controlled with treatment and have not changed much recently) -Not have a positive COVID-19 test within 2 weeks prior to receiving the first injection -Be free from exposure to someone with SARS-CoV-2 infection or COVID-19 within 2 weeks prior to receiving the first injection -Not have received an investigational pediatric vaccine or treatment for COVID-19 -Have parent(s)/caregiver(s) who understand and are willing and physically able to comply with protocol-mandated follow-up
Prevention
Childrens Hospital Colorado
Elizabeth Mcfarland, MD
Protocol Number: 22-1736
More information available at ClinicalTrials.gov: NCT05584202
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