NCT05249829

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19

A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,548 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 and mRNA-1273.214 administered as a booster dose.

Detailed description

In Part 1, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.529 or mRNA-1273. In Part 2, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.214 or mRNA-1273. All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 3rd dose, and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose (a mixed approach is acceptable). Each part will include Phase A (randomized, blinded) and Phase B (open-label, observational).

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273.529	Sterile liquid for injection
BIOLOGICAL	mRNA-1273	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.214	Sterile liquid for injection

Timeline

• Start date: 2022-02-16
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2022-02-22
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

29 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study