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Efficacy and Safety of NVX-CoV2705

NCT07086222 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6500

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-11-18
Completion
2026-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086222 on ClinicalTrials.gov