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Safety and Immunogenicity of NVX-CoV2705

NCT07079670 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2026-02-13

No results posted yet for this study

Summary

This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 and older, and individuals aged 12 to 64 who have existing health conditions that put them at high risk for severe COVID-19. All participants must have received a previous COVID-19 vaccine at least 90 days before joining this study. Study researchers will be closely monitoring participants for their immune response for 28 days and collecting safety data for 180 days after vaccination.

Conditions

Interventions

BIOLOGICAL

NVX-CoV2705

Intramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.

Sponsors & Collaborators

  • Novavax

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2026-04-16
Completion
2026-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07079670 on ClinicalTrials.gov