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NCT04649151 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
A Phase 2 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 4,328
- Enrollment target
NCT04649151: Completed Phase 2 study, sponsored by ModernaTX.
NCT04649151 is a Phase 2 study that has completed, run by ModernaTX. The registered enrollment target is 4,328 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (3154% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04649151, a Phase 2 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4,328 participants
- Enrollment target
Study Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.
Primary Outcome
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy A
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1273
- BIOLOGICAL mRNA-1273.222
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,328 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2024-06-14 |
| Phase | Phase 2 |
What the finished NCT04649151 record still lists
NCT04649151 is an interventional study that assigns participants to a tested intervention. Its 4,328 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 (3154% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04649151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04649151 about?
NCT04649151 is a clinical study titled "A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19". The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series...
What is the current status of trial NCT04649151?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4,328 participants. The study started on 2020-12-09. Estimated completion is 2024-06-14.
What interventions are being tested in trial NCT04649151?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1273 (BIOLOGICAL), mRNA-1273.222 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04649151?
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 NCT04649151's enrollment target sits among peer trials
4,328 2nd of 2000 the highest 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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