NCT07086222

Efficacy and Safety of NVX-CoV2705

A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Post-Marketing Study to Evaluate the Efficacy and Safety of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M® in Adults 50 to < 65 Years of Age Without High Risk Conditions for Severe COVID-19

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,500 (estimated)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.

Detailed description

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, post-marketing study to evaluate the efficacy and safety of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M (NVX-CoV2705) in adults 50 to \< 65 years of age who are not considered to be at high risk of severe coronavirus disease 2019 (COVID-19). This study will be conducted in the United States (US). Approximately 6,500 participants will be randomized in a 1:1 ratio via block randomization to receive a single intramuscular (IM) injection of NVX-CoV2705 or placebo (normal saline) on Day 0 and remain on study for efficacy and safety data collection through Day 180/end of study (EoS).

Conditions

• COVID-19
• Sars-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	NVX-CoV2705	NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant
BIOLOGICAL	Placebo	Placebo (normal saline) in a 0.5 mL injection volume.

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-01-09
• Completion: 2026-07-09
• First posted: 2025-07-25
• Last updated: 2025-08-03