NCT05584202

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

A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this pediatric study was to confirm safety and effectiveness of mRNA-1273.214 in infants between 12 weeks to \< 6 months of age by comparing the immune response of infants in this study to adults (\>18 years of age) enrolled in the mRNA-1273-P301 study \[NCT04470427\]). The study was planned to be conducted in 2 parts. Part 1 was open-label and evaluated 2 dose levels. The dose level selected from Part 1 was planned to be further evaluated in Part 2. However, data from the dose finding part of the trial (Part 1) did not support further evaluation of effectiveness of mRNA-1273 and accordingly, Part 2 of the study was not conducted and the trial was terminated. There were no safety concerns.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273.214	Sterile liquid for injection
OTHER	Placebo	0.9% sodium chloride

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2022-10-18
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study