NCT04796896

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 2/3, 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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11,942 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years. Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273	Sterile liquid for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection
BIOLOGICAL	mRNA-1273.214	Sterile liquid for injection

Timeline

• Start date: 2021-03-15
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2021-03-15
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

91 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study