At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 11,942 enrolled
Drug / intervention
mRNA-1273 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
In Brief
A Phase 3 clinical trial evaluating mRNA-1273, Placebo, and 1 other intervention for SARS-CoV-2. Completed, enrolled 11,942 participants across 91 sites in 2 countries.
Detailed Summary
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartMar 2021
Primary CompletionMar 2024
TodayJul 2026
First PostedMar 15, 2021
Enrollment StartMar 15, 2021
Primary CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 5.3 years ago
Interventions
mRNA-1273biological
Sterile liquid for injection
Placebobiological
0.9% sodium chloride (normal saline) injection
mRNA-1273.214biological
Sterile liquid for injection