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NCT04796896 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
A Phase 2 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 11,942
- Enrollment target
NCT04796896: Completed Phase 2 study, sponsored by ModernaTX.
NCT04796896 is a Phase 2 study that has completed, run by ModernaTX. The registered enrollment target is 11,942 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (8879% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04796896, a Phase 2 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11,942 participants
- Enrollment target
Study 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).
Primary Outcome
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs)
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1273
- BIOLOGICAL mRNA-1273.214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,942 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2024-03-15 |
| Phase | Phase 2 |
What the finished NCT04796896 record still lists
NCT04796896 is an interventional study that assigns participants to a tested intervention. Its 11,942 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (8879% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04796896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04796896 about?
NCT04796896 is a clinical study titled "A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age". 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).
What is the current status of trial NCT04796896?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11,942 participants. The study started on 2021-03-15. Estimated completion is 2024-03-15.
What interventions are being tested in trial NCT04796896?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1273 (BIOLOGICAL), mRNA-1273.214 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04796896?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04796896's enrollment target sits among peer trials
11,942 1st of 2000 higher than 2,000 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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