Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05584202 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
A Phase 2 study, sponsored by ModernaTX.
- Terminated
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT05584202: Clinical Trial Phase 2 study, sponsored by ModernaTX.
NCT05584202 is a Phase 2 study that was terminated before completion, run by ModernaTX. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05584202, a Phase 2 study, was terminated before completion, sponsored by ModernaTX.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to \<6 months) of the Toxi
Interventions
- OTHER Placebo
- BIOLOGICAL mRNA-1273.214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2024-11-15 |
| Phase | Phase 2 |
Why NCT05584202 stopped before completion
NCT05584202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05584202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05584202 about?
NCT05584202 is a clinical study titled "Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants". 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.
What is the current status of trial NCT05584202?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2022-09-30. Estimated completion is 2024-11-15.
What interventions are being tested in trial NCT05584202?
The interventions under investigation include: Placebo (OTHER), mRNA-1273.214 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05584202?
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 NCT05584202's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI