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Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants

NCT05584202 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-11-26

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

mRNA-1273.214

Sterile liquid for injection

OTHER

Placebo

0.9% sodium chloride

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584202 on ClinicalTrials.gov