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 (BabyCOVE)
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- STATUS
- Recruiting
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- End date
- Mar 8, 2025
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- participants needed
- 700
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- sponsor
- ModernaTX, Inc.
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.
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]).
Details
| Condition | SARS-CoV-2 |
|---|---|
| Treatment | Placebo, mRNA-1273.214 |
| Clinical Study Identifier | NCT05584202 |
| Sponsor | ModernaTX, Inc. |
| Last Modified on | 28 October 2022 |
Eligibility
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