NCT05463068

Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 911 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.

Detailed description

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	NVX-Cov2373	Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Timeline

• Start date: 2022-07-11
• Primary completion: 2022-08-17
• Completion: 2022-09-01
• First posted: 2022-07-18
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study