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Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants — BabyCOVE  

SARS-CoV-2 Clinical Trial

Official title:
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

Clinical Trial Summary

The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months.

Clinical Trial Description

The study will be conducted in 2 parts. Part 1 will be open-label and evaluate 2 dose levels. The dose level selected from Part 1 will be further evaluated in Part 2, which will be blinded and randomized. This pediatric study is intended to confirm safety and effectiveness of mRNA-1273.214 in infants between 12 weeks to < 6 months of age by comparing the immune response of infants in this study to adults (>18 years of age) enrolled in the mRNA-1273-P301 study [NCT04470427]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05584202
Study type Interventional
Source ModernaTX, Inc.
Contact Moderna Clinical Trials Support Center
Phone 1-877-777-7187
Email clinicaltrials@modernatx.com
Status Recruiting
Phase Phase 2
Start date September 30, 2022
Completion date March 8, 2025
View Details
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