Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05584202
Status:
TERMINATED
Last Update Posted:
2025-11-26
First Post:
2022-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
Sponsor:
ModernaTX, Inc.
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was terminated because data from the dose finding part of the trial did not support further evaluation of effectiveness of mRNA-1273. There were no safety concerns.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BabyCOVE
Brief Summary:
The study evaluated 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.
Detailed Description:
The purpose of this pediatric study was 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 \[NCT04470427\]).
The study was planned to be conducted in 2 parts. Part 1 was open-label and evaluated 2 dose levels. The dose level selected from Part 1 was planned to be further evaluated in Part 2. However, data from the dose finding part of the trial (Part 1) did not support further evaluation of effectiveness of mRNA-1273 and accordingly, Part 2 of the study was not conducted and the trial was terminated. There were no safety concerns.
The study was planned to be conducted in 2 parts. Part 1 was open-label and evaluated 2 dose levels. The dose level selected from Part 1 was planned to be further evaluated in Part 2. However, data from the dose finding part of the trial (Part 1) did not support further evaluation of effectiveness of mRNA-1273 and accordingly, Part 2 of the study was not conducted and the trial was terminated. There were no safety concerns.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: